{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 1185 } }, "results": [ { "effective_time": "20121129", "inactive_ingredient": [ "Inactive Ingredients: Acacia gum, lactose, magnesium stearate, starch, sucrose." ], "purpose": [ "Temporarily relieves dizziness and nausea" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children." ], "warnings": [ "Warnings: If symptoms persist or worsen, consult a healthcare professional." ], "spl_product_data_elements": [ "VertiFree Bryonia , Cocculus, Gelsemium, Lobelia inf, Acacia gum, lactose, magnesium stearate, corn starch, sucrose BRYONIA ALBA ROOT BRYONIA ALBA ROOT ACACIA LACTOSE MAGNESIUM STEARATE STARCH, CORN SUCROSE ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT LOBELIA INFLATA LOBELIA INFLATA white lactose tablets round white lactose tablets none" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Chew or dissolve tablets in the mouth.Alternatively, for small babies, crush tablets and sprinkle onto tongue or mix in warm water or soft food.For all ages: Takes 2 tablets 3 times daily until symptoms subside." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use." ], "storage_and_handling": [ "Tamper resistant for your protection. Use only if safety seal is intact." ], "information_for_patients": [ "The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com Distributed by Native Remedies, LLC 6531 Park of Commerce Blvd. Suite 160 Boca Raton, FL 33487 Phone: +1.877.289.1235 International:+1.561.99.8857 Contains no artificial flavors or artificial colors. No gluten added." ], "package_label_principal_display_panel": [ "Bottle Label" ], "indications_and_usage": [ "Uses: Homeopathic remedy for the temporary symptom relief of dizziness and nausea." ], "set_id": "00962471-6362-4353-9439-6711ed5ef694", "id": "c49d071d-21cd-443c-a782-8867b0c9dc7c", "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away." ], "active_ingredient": [ "Active Ingredients: Each tablet contains equal parts of: Bryonia (30C) (HPUS), Cocculus (30C) (HPUS), Gelsemium (30C) (HPUS), Lobelia inf (30C) (HPUS)." ] }, { "effective_time": "20140127", "inactive_ingredient": [ "Inactive Ingredients: purified water, natural flavors, liquid sucrose, citric acid, xanthan gum, luo han guo concentrate" ], "purpose": [ "Concentrated Liquid Shot NicFix ™ For when you CAN'T SMOKE... or CHOOSE not to Lemon Drop 2 fl. oz. (59 mL)" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Suggested use: 18 years of age or older" ], "warnings": [ "Warning: do not use if you are pregnant or lactating or have phenylketonuria. Consult your doctor or health care professional before use if you are taking prescription medication for depression such as MAO inhibitors or have asthma, high blood pressure, stomach ulcers, diabetes, or hyperthyroidism. Nicotine or caffeine can increase your heartrate. This product contains nicotine, a chemical known to the state of California to cause birth defects or other reproductive harm. Caution: for any suspected or known illness or dysfunction, always consult your physician or medical adviser first." ], "spl_product_data_elements": [ "NicFix Nicotine NICOTINE NICOTINE TYROSINE TYROSINE PHENYLALANINE PHENYLALANINE TRYPTOPHAN TRYPTOPHAN CAFFEINE CAFFEINE CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID SUCRALOSE SODIUM BENZOATE WATER XANTHAN GUM SIRAITIA GROSVENORII FRUIT" ], "other_safety_information": [ "ONCE OPENED USE WITHIN 48 HOURS Patented process NDC 42638-7665-2 Distributed by Nico Worldwide, Inc. NicFix is a product of Nico Worldwide, Inc. 320 Irving Dr., Oxnard, CA 93030 www.nicoworldwide.com" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "SAFE TO USE WHILE SMOKING Directions: Use as required. Do not use nicotine cessation products while using this product. Homeopathic Nicotinum Complex. Registered as a homeopathic remedy. www.getyournicfix.com" ], "package_label_principal_display_panel": [ "label image" ], "indications_and_usage": [ "REFRIGERATE AFTER OPENING Indications: Use when smoking is not allowed or when you should not smoke Recommended for late afternoon or evening use" ], "set_id": "00a58408-97c6-4e08-9595-da4b8653b956", "id": "9a75311e-6f33-4772-878f-d50b2372a21f", "active_ingredient": [ "Ingredients: SNRA (Nicotinum 6X) In a base of: buffered caffeine anhudrous, L-tyrosine, L-tryptophan, L-phenylalanine" ] }, { "effective_time": "20111115", "inactive_ingredient": [ "Inactive ingredients Corn Syrup, FD&C Red 40, FD&C Blue 1, Flavors, Menthol, Purified Water, Sucrose, Titanium Dioxide." ], "purpose": [ "Purpose Cough Suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions Call 1-800-344-7239 or write to Consumer Affairs." ], "spl_product_data_elements": [ "Sucrets Cough Cherry Dextromethorphan Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CORN SYRUP FD&C RED NO. 40 FD&C BLUE NO. 1 MENTHOL WATER SUCROSE TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: take 3 lozenges every 6-8 hours, do not take more than 12 lozenges per day children 6 to under 12 years of age: take 1 lozenge every 4 hours, do not take more than 6 lozenges per day children 4 to under 6 years of age: ask a doctor do not use in children under 4 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 18 Lozenge Box SAFETY SEALED: Do not use if foil imprinted with \"Sucrets\" is torn or missing SUCRETS ® Dextromethorphan Hydrobromide–Cough Suppressant 8 Hour Cough Relief DMCOUGH FORMULA Made Stronger To Last Longer! ® 18 COUGH LOZENGES CHERRY Principle Display Panel - 18 Cough Lozenge Box" ], "indications_and_usage": [ "Uses temporarily suppresses coughs due to minor throat and bronchial irritation associated with a cold or inhaled irritants" ], "set_id": "00ad5b08-5371-4a2f-be49-4254106d7f64", "id": "3445f758-b0eb-4c92-aebf-0b67153848b1", "active_ingredient": [ "Active ingredient (per lozenge) Dextromethorphan Hydrobromide 10mg" ] }, { "effective_time": "20120717", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, GLYCERIN, NIACINAMIDE VITAMIN B3, , DIMETHICONE, ISOPROPYL ISOSTEARATE, POLYACRYLAMIDE, TRIETHANOLAMINE, ZINC OXIDE, SODIUM ASCORBYL PHOSPHATE, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, C13-14 ISOPARAFFIN, CETYL ALCOHOL, PTFE, PANTHENOL PRO-VITAMIN B5, , TOCOPHERYL ACETATE VITAMIN E , BENZYL ALCOHOL, TITANIUM DIOXIDE, BEHENYL ALCOHOL, DIMETHICONOL, SUCROSE POLYCOTTONSEEDATE, ETHYLPARABEN, CARBOMER, LAURETH-7, METHYLPARABEN, PROPYLPARABEN, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, DISODIUM EDTA, STEARIC ACID, AMMONIUM POLYACRYLATE, BHT, PEG-4, PEG-4 LAURATE, PEG-4 DILAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRIETHOXYCAPRYLYLSILANE." ], "purpose": [ "the result? Visibly younger-looking skin that's better protected against sun damage." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "WARNING FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN." ], "when_using": [ "FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER." ], "questions": [ "Questions? 1-800-285-5170 www.olay.com" ], "spl_product_data_elements": [ "Olay Total Effects UV Moisturizer SPF 15 Fragrance Free Octisalate, Avobenzone, Ensulizole, and Octocrylene Octisalate Octisalate Avobenzone Avobenzone Ensulizole Ensulizole Octocrylene Octocrylene WATER GLYCERIN NIACINAMIDE DIMETHICONE TROLAMINE ZINC OXIDE SODIUM ASCORBYL PHOSPHATE GREEN TEA LEAF STEARYL ALCOHOL C13-14 ISOPARAFFIN CETYL ALCOHOL PANTHENOL .ALPHA.-TOCOPHEROL BENZYL ALCOHOL TITANIUM DIOXIDE DOCOSANOL ETHYLPARABEN LAURETH-7 METHYLPARABEN PROPYLPARABEN CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL EDETATE DISODIUM STEARIC ACID BUTYLATED HYDROXYTOLUENE PEG-4 DILAURATE IODOPROPYNYL BUTYLCARBAMATE TRIETHOXYCAPRYLYLSILANE" ], "ask_doctor": [ "IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "directions Apply liberally before sun exposure on face and neck as often as necessary each day to help protect your skin from harmful UV rays while keeping skin soft and smooth. Gentle enough for everyday use. Designed to replace your moisturizer and specialty skin care products. Children under six months of age: consult a doctor." ], "stop_use": [ "DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR." ], "spl_unclassified_section": [ "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 mL Carton OLAY ® total effects ® 7-IN-1 ANTI-AGING UV MOISTURIZER plus SPF 15 | fragrance-free 7 anti-aging therapies in 1 vitamin and anti-oxidant moisturizer +UVA/UVB for visibly younger-looking and protected skin 1.7 FL OZ (50 mL) BROAD SPECTRUM SPF 15 UVA/UVB SUNSCREEN Principal Display Panel - 50 mL Carton" ], "indications_and_usage": [ "how does it work? It provides the total anti-aging power of moisture with vitamins and anti-oxidants plus UVA/UVB (SPF 15) protection to help prevent sun damage. Use the Total Effects system for your anti-aging regimen: Total Effects 7-in-1 Cleansers Total Effects 7-in-1 Boosters" ], "set_id": "00c6d639-6700-4a39-96d5-9865531425d2", "id": "a77cd5ca-875d-4f55-b73e-5025c86b5213", "active_ingredient": [ "ACTIVE INGREDIENTS 4.0% OCTISALATE, 2.0% AVOBENZONE, 1.0% ENSULIZOLE, 1.0% OCTOCRYLENE." ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children" ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Tinnitus Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata Aconitum Napellus Aconitum Napellus Barium Carbonate Barium Cation Barium Chloride Dihydrate Barium Cation Capsicum Capsicum Causticum Causticum Dysphania Ambrosioides Dysphania Ambrosioides Quinine Sulfate Quinine Cinchona Officinalis Bark Cinchona Officinalis Bark Nitroglycerin Nitroglycerin Graphite Graphite Goldenseal Goldenseal Potassium Dichromate Dichromate Ion Potassium Chloride Potassium Cation Lycopodium Clavatum Spore Lycopodium Clavatum Spore Phosphorus Phosphorus Pulsatilla Vulgaris Pulsatilla Vulgaris Salicylic Acid Salicylic Acid Tobacco Leaf Tobacco Leaf Allylthiourea Allylthiourea Viola Odorata Viola Odorata Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Tinnitus Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise." ], "set_id": "00f6bd07-e6a9-5e16-1a4a-e51c5901fd9e", "id": "2c8847e3-e129-6b7d-ff3e-832fd636f527", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x, Hydrastis 8x, Hydrastis 3x." ] }, { "effective_time": "20111217", "inactive_ingredient": [ "I nactive Ingredients sucrose, calcium carbonate, corn starch, talc, mineral oil, calcium sterate, natural flavor and artificial flavor, adpic acid, Yellow No. 5, Yellow No. 6, Red No. 6, Red No. 30, Red No. 27 and Blue No. 1" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs" ], "when_using": [ "When using this product -do not take more than 15 tablets in 24 hours -do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-877 2198302" ], "spl_product_data_elements": [ "CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SUCROSE STARCH, CORN TALC MINERAL OIL CALCIUM STEARATE ADIPIC ACID FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 D&C RED NO. 6 D&C RED NO. 30 D&C RED NO. 27 FD&C BLUE NO. 1 mixed fruit Tablet CALCID orange, yellow, red" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Antacid -chew 2-4 tablets as symptoms occur or as directed by a doctor" ], "spl_unclassified_section": [ "Other information - for calcium content see Supplement Facts. - Store below30°C (86°F) - do not use if printed seal under cap is torn or missing CALCIUM SUPPLEMENT Uses: As a daily source of extra calcium Directions: chew 2 tablets twice daily with meal Supplement Facts Serving Size: 2 Tablets Servings Per Container: 50 Amount %Daily Per Serving Value Calories 5 Sugars 1g Calcium 400mg 40%" ], "package_label_principal_display_panel": [ "Package Label image of package label" ], "indications_and_usage": [ "Uses relieves: heartburn, sour stomach, acid indigestion, upset stomach associated with these symptoms" ], "set_id": "011bf4be-5e8c-47ae-9fbd-2b01da32696a", "id": "bd78021d-079f-4bfb-bfce-efff02835f00", "active_ingredient": [ "Active Ingredient (per tablet) Calcium carbonate USP 500 mg" ] }, { "effective_time": "20111101", "inactive_ingredient": [ "Inactive Ingredient: Lactose and Sucrose. Free from yeast, wheat, corn and soy." ], "purpose": [ "PMS, CRAMPING, HEADACHE, OR OTHER INDICATIONS LACHESIS MUTA VENOM" ], "keep_out_of_reach_of_children": [ "WARNING: Keep this and all medications out of reach of children." ], "warnings": [ "WARNING: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area." ], "questions": [ "Questions or comments .(877)REM4YOU. Fax (909)594-4205 Pomona, CA. 91768. USA www.remedymakers.com Other information: Contain approx.147 - 155 pellets. LACHESISMUTUS12C" ], "spl_product_data_elements": [ "LACHESIS MUTUS BUSHMASTER VENOM LACHESIS MUTA VENOM LACHESIS MUTA VENOM SUCROSE LACTOSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions : (adult/children) Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 the adult dose." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "INDICATIONS: To be use according to standard homeopathic indications, for self-limiting conditions such as these indicated above or as directed by a physician." ], "set_id": "013689ea-62e1-498a-a53e-fed7767e451e", "id": "b37faf2d-22b7-4196-a794-0c33cf226a6e", "active_ingredient": [ "LACHESIS MUTA VENOM" ] }, { "spl_product_data_elements": [ "Dolichos pruriens MUCUNA PRURIENS FRUIT TRICHOME MUCUNA PRURIENS FRUIT TRICHOME MUCUNA PRURIENS FRUIT TRICHOME SUCROSE LACTOSE white" ], "active_ingredient": [ "ACTIVE INGREDIENTS DOLICHOS" ], "purpose": [ "USES To relieve the symptoms of itching." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children." ], "indications_and_usage": [ "INDICATIONS Indications: DOLICHOS Itching" ], "warnings": [ "STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner." ], "dosage_and_administration": [ "DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose/Lactose" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL The OTC potency range of DOLICHOS is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM. Availability is subject to change. All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled. ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice. Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. Dolichos label example" ], "set_id": "0144ecee-ab48-4f07-921a-8f64e52c0d23", "id": "3726b468-a5b1-46aa-b346-28ba414a3edb", "effective_time": "20110601", "version": "1", "openfda": {} }, { "effective_time": "20110826", "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: runny nose and sneezing cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "015d6dbd-d537-4c14-80c3-a7d4ed077fbf", "id": "6038afb7-254e-4b5c-b586-f5833c75c8d3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each 15 ml tablespoon) Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children. marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "spl_product_data_elements": [ "Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SUCROSE SUCRALOSE DOXYLAMINE SUCCINATE DOXYLAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information each 30 mL dose cup contains: sodium 43 mg store at room temperature" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 yrs and over 30 ml (2 Tbsp) every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep" ], "package_label_principal_display_panel": [ "Package label Night Time Cold/Flu Relief Original image of bottle label" ], "overdosage": [ "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20100827", "inactive_ingredient": [ "Sucrose (inactive ingredient)." ], "purpose": [ "Relieves pain, crankiness and crying during teething" ], "keep_out_of_reach_of_children": [ "Keep this and all medicines from the reach of children." ], "warnings": [ "Contains no gluten, artificial flavors, colors or preservatives.Safe for all ages." ], "spl_product_data_elements": [ "Oral Soothe Passiflora, Chamomilla, Calc fluor, Calc phos, Chamomilla PASSIFLORA INCARNATA TOP PASSIFLORA INCARNATA TOP MATRICARIA RECUTITA MATRICARIA RECUTITA CALCIUM FLUORIDE CALCIUM CATION ANHYDROUS DIBASIC CALCIUM PHOSPHATE CALCIUM CATION MATRICARIA RECUTITA MATRICARIA RECUTITA SUCROSE white sucrose granules" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Dosage: Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed." ], "general_precautions": [ "Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children." ], "information_for_patients": [ "All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com Distributed by Native Remedies, LLC 6531 Park of Commerce Blvd. Suite 160 Boca Raton, FL 33487 Phone: 1.877.289.1235 International: + 1.561.999.8857 The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States." ], "package_label_principal_display_panel": [ "bottle label" ], "indications_and_usage": [ "Indications: Soothing homeopathic remedy for teething in babies and children." ], "set_id": "016b8e20-b260-44cc-a851-6ade29e60488", "id": "4d3ab8fa-4961-4dd0-8361-e7c92e3bb5f6", "active_ingredient": [ "Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)" ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating ." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Dizziness - Vertigo Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana Wormwood Wormwood Aconitum Napellus Aconitum Napellus Antimony Potassium Tartrate Antimony Cation (3+) Atropa Belladonna Atropa Belladonna Bryonia Alba Root Bryonia Alba Root Phenol Phenol Colchicum Autumnale Bulb Colchicum Autumnale Bulb Conium Maculatum Flowering Top Conium Maculatum Flowering Top Iron Iron Gelsemium Sempervirens Root Gelsemium Sempervirens Root Nitroglycerin Nitroglycerin Hyoscyamus Niger Hyoscyamus Niger Ipecac Ipecac Iris Versicolor Root Iris Versicolor Root Lycopodium Clavatum Spore Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Kerosene Kerosene Phosphorus Phosphorus Sepia Officinalis Juice Sepia Officinalis Juice Symphoricarpos Albus Fruit Symphoricarpos Albus Fruit Tobacco Leaf Tobacco Leaf Theridion Curassavicum Theridion Curassavicum Ginger Ginger Echinacea, Unspecified Echinacea, Unspecified Hypericum Perforatum Hypericum Perforatum Passiflora Incarnata Flowering Top Passiflora Incarnata Flowering Top Valerian Valerian Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Dizziness - Vertigo Formulated for symptoms associated with vertigo such as dizziness, disequilibrium, presyncope, nausea and sensations of motion, spinning or floating ." ], "set_id": "019b93c7-aaa4-b0f8-8ad0-f1bb5f99ad17", "id": "49890bd2-de92-ef17-3c9d-94733802f0ae", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Absinthium 20x, Aconitum nap. 20x, Antimon. tart. 20x, Belladonna 20x, Bryonia 20x, Carbolicum acidum 20x, Colchicum 20x, Conium 20x, Ferrum metallicum 20x, Gelsemium 20x, Glonoinum 20x, Hyoscyamus 20x, Ipecac. 20x, Iris versicolor 20x, Lycopodium 20x, Nux vom. 20x, Petroleum 20x, Phosphorus 20x, Sepia 20x, Symphoricarpus racemosus 20x, Tabacum 20x, Theridion 20x, Zingiber 20x, Echinacea 8x, Hypericum 8x, Passiflora 8x, Valeriana 8x, Echinacea 3x, Hypericum 3x, Passiflora 3x, Valeriana 3x." ] }, { "effective_time": "20101018", "inactive_ingredient": [ "80% sucrose / 20% lactose" ], "purpose": [ "SWELLING, HIVES , OR OTHER INDICATIONS" ], "keep_out_of_reach_of_children": [ "WARNING: Keep this and all medications out of reach of children." ], "warnings": [ "WARNING SECTION: Use only if cap and seal are unbroken. If symptoms persist for more then 3 days, consult your physician. As with any drug, if your pregnant or nursing a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768" ], "spl_product_data_elements": [ "APIS MELLIFICA BEE VENOM APIS MELLIFERA APIS MELLIFERA SUCROSE LACTOSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: Dissolve 3 or 4 in mouth or tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose." ], "package_label_principal_display_panel": [ "APIS MELLIFICA 12X" ], "indications_and_usage": [ "INDICATIONS: To be used according to standard homeopathic indications for self limiting conditions such as those indicated on the front panel or as directed by a physician. Free from yeast, wheat, corn, and soy." ], "set_id": "021ee685-794a-4524-b9cc-75b71e236a34", "id": "a1e43089-21cc-4827-91dc-9d0b1ad2dd20", "active_ingredient": [ "APIS MELLIFERA SWELLING, HIVES , OR OTHER INDICATIONS WARNING: Keep this and all medications out of reach of children. INDICATIONS: To be used according to standard homeopathic indications for self limiting conditions such as those indicated on the front panel or as directed by a physician. Free from yeast, wheat, corn, and soy. WARNING SECTION: Use only if cap and seal are unbroken. If symptoms persist for more then 3 days, consult your physician. As with any drug, if your pregnant or nursing a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768 DIRECTIONS: Dissolve 3 or 4 in mouth or tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose. 80% sucrose / 20% lactose" ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients Corn syrup, D&C yellow #10, FD&C blue #1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water" ], "purpose": [ "Purpose Oral anesthetic Oral anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 12 years of age. Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-634-7680" ], "spl_product_data_elements": [ "Otis Clapp Thorets HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N Medi-First Plus Sore Throat Max HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed Adults and children: (12 years and older) Allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all warnings and directions before use. TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering. store at room temperature 15º-30ºC (59º-86ºF) protect from moisture" ], "stop_use": [ "Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "package_label_principal_display_panel": [ "909B MFP Sore Throat Max Label 100 Lozenges 100 Pastillas Medi First® Plus Sore Throat Max Pull to Open Anesthetic Throat Lozenges Pastillas para el alivio del dolor de garganta Individually wrapped Throat Lozenges Individualmente Envuelto Pastillas para alivio del dolor de garganta Figure", "909B OC Thorets Label Otis Clapp Quality and Integrity Since 1840 THORETS ™ Sore Throat Lozenges Maximum Strength Anesthetic Throat Lozenges New Formula! Hexylresorcinol 2.4 mg Menthol 4.5 mg Tear Out Along Perforation To Dispense PROFESSIONAL HEALTHCARE 300 Lozenges Figure" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms occasional minor irritation pain sore mouth sore throat" ], "set_id": "022d0c43-baba-4523-9ffd-6beb5ef9dd03", "id": "3cc46011-479c-494f-a24a-573783c2588c", "active_ingredient": [ "Active ingredient (in each lozenge) Hexylrescorcinol 2.4mg Menthol 4.5mg" ] }, { "effective_time": "20110628", "inactive_ingredient": [ "inactive ingredients: water\\aqua\\eau [] dimethicone [] butyloctyl salicylate [] polyester-8 [] butylene glycol [] cetearyl alcohol [] silica [] glyceryl stearate [] peg-100 stearate [] glycerin [] hydrogenated lecithin [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] padina pavonica (thallus) extract [] petrolatum [] isopropyl ppg-2-isodeceth-7 carboxylate [] sea whip extract [] jojoba esters [] adenosine phosphate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] lauroyl lysine [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] sucrose [] micrococcus lysate [] astrocaryum murumuru seed butter [] cetearyl glucoside [] laurdimonium hydroxypropyl hydrolyzed soy protein [] dimethiconol [] lecithin [] algae extract [] hexylene glycol [] ethylhexyl stearate [] ethylhexyl palmitate [] propylene glycol dicaprate [] chamomilla recutita (matricaria) [] caprylyl glycol [] isohexadecane [] polyethylene [] ethylhexylglycerin [] zeolite [] behenyl alcohol [] polysorbate 80 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] acrylates/c10-30 alkyl acrylate crosspolymer [] tromethamine [] arginine ferulate [] decarboxy carnosine hcl [] xanthan gum [] sodium chloride [] potassium sulfate [] disodium edta [] phenoxyethanol" ], "warnings": [ "warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL: CLINIQUE SUPERDEFENSE SPF AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION SKIN NT WT. 1.7 OZ./50 ML CLINIQUE LABORATORIES INC, DISTR NEW YORK, NY 10022 FOLDING CARTON" ], "spl_product_data_elements": [ "SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION OXYBENZONE, OCTISALATE, AVOBENZONE OXYBENZONE OXYBENZONE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE WATER DIMETHICONE PETROLATUM BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE POLYGLYCERYL-4 ISOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOSTEARATE PEG-100 STEARATE ROBUSTA COFFEE BEAN ECHINACEA PALLIDA ROSEMARY PSEUDOPTEROGORGIA ELISABETHAE SACCHAROMYCES LYSATE TREHALOSE CREATINE CAFFEINE MASOPROCOL ASTROCARYUM MURUMURU SEED BUTTER LINOLEIC ACID CHOLESTEROL LAMINARIA DIGITATA HYALURONATE SODIUM ALPHA-TOCOPHEROL ACETATE ADENOSINE PHOSPHATE DISODIUM MATRICARIA RECUTITA ETHYLHEXYL STEARATE CAPRYLYL GLYCOL ISOHEXADECANE LECITHIN, SOYBEAN DOCOSANOL XANTHAN GUM POTASSIUM SULFATE POLYSORBATE 80 STEARETH-21 SUCROSE TROMETHAMINE CARBOMER HOMOPOLYMER TYPE C GLYCERIN ETHYLHEXYL PALMITATE PROPYLENE GLYCOL DICAPRATE HEXYLENE GLYCOL EDETATE DISODIUM PHENOXYETHANOL CETEARYL GLUCOSIDE LAUROYL LYSINE HYDROGENATED SOYBEAN LECITHIN" ], "set_id": "02e18eef-3ef1-4f02-a031-c127d0836f31", "id": "df1d5fe1-1708-49e2-a9cd-5a473c822202", "openfda": {}, "version": "1", "active_ingredient": [ "active ingredients: octisalate 5.00% [] oxybenzone 5.00% [] avobenzone 3.00%" ] }, { "spl_product_data_elements": [ "Alfalfa ALFALFA ALFALFA ALFALFA SUCROSE LACTOSE white" ], "active_ingredient": [ "ACTIVE INGREDIENTS ALFALFA 30C" ], "purpose": [ "USES To relieve the symptoms of fainting." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children." ], "indications_and_usage": [ "INDICATIONS Indications: ALFALFA Nervousness" ], "warnings": [ "STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner." ], "dosage_and_administration": [ "DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose/Lactose" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL The OTC potency range of ALFALFA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM. Availability is subject to change. All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled. ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice. Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. Alfalfa label example" ], "set_id": "03090c9b-18b7-4da6-aa49-65af9525fe3e", "id": "d87b455b-79c6-4d11-88ba-4f850ae62f67", "effective_time": "20110517", "version": "1", "openfda": {} }, { "effective_time": "20151031", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Sick Headache" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "THEA SINENSIS THEA SINENSIS GREEN TEA LEAF GREEN TEA LEAF SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "03134a9b-ce4f-4b10-a5eb-3e47dc4cf6c1", "id": "a63b88e5-6c60-4d0b-ab87-31559d7326d2", "active_ingredient": [ "ACTIVE INGREDIENT THEA SINENSIS HPUS 1X and higher" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "INGREDIENTS WATER\\AQUA\\EAU • CYCLOPENTASILOXANE • PHENYL TRIMETHICONE • BUTYLENE GLYCOL • CETYL DIMETHICONE • DIMETHICONE • PENTAERYTHRITYL TETRAETHYLHEXANOATE • OCTYLDODECYL STEAROYL STEARATE • PEG/PPG-18/18 DIMETHICONE • CETYL PEG/PPG-10/1 DIMETHICONE • MAGNESIUM SULFATE • SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT • TOCOPHERYL ACETATE • ASCORBYL PALMITATE • CAFFEINE • SODIUM HYALURONATE • 7-DEHYDROCHOLESTEROL • PHYTOSPHINGOSINE • PEG-8 • SUCROSE • CHOLESTEROL • LAURETH-7 • LINOLEIC ACID • HYDROGENATED LECITHIN • METHICONE • DISTEARDIMONIUM HECTORITE • PALMITOYL OLIGOPEPTIDE • XANTHAN GUM • ZINC STEARATE • TRIMETHYLSILOXYSILICATE • GLYCERYL POLYMETHACRYLATE • TRIETHYL CITRATE • ALUMINA • FRAGRANCE (PARFUM) • BHT • PHENOXYETHANOL • CHLOROXYLENOL • IMIDAZOLIDINYL UREA • [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891) • MICA] " ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "WARNING Keep out of eyes. Stop use if irritation occurs. Keep out of reach of children." ], "when_using": [ "Keep out of eyes." ], "spl_product_data_elements": [ "RE-NUTRIV INTENSIVE LIFTNG MAKE UP SPF15 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE PENTAERYTHRITYL TETRAETHYLHEXANOATE OCTYLDODECYL STEAROYL STEARATE MAGNESIUM SULFATE, UNSPECIFIED MILK THISTLE ALPHA-TOCOPHEROL ACETATE ASCORBYL PALMITATE CAFFEINE HYALURONATE SODIUM 7-DEHYDROCHOLESTEROL POLYETHYLENE GLYCOL 400 SUCROSE CHOLESTEROL LAURETH-7 LINOLEIC ACID HYDROGENATED SOYBEAN LECITHIN PALMITOYL OLIGOPEPTIDE XANTHAN GUM ZINC STEARATE TRIETHYL CITRATE ALUMINUM OXIDE BUTYLATED HYDROXYTOLUENE PHENOXYETHANOL CHLOROXYLENOL IMIDUREA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use if irritation occurs." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 ml CARTON ESTĒE LAUDER Re-Nutriv Intensive Lifting Makeup SPF 15 POIDS NET WT. 1.1 OZ./30 ml e Principal Display Panel - 30 ml CARTON" ], "set_id": "0391ab4c-28e6-4e13-94ca-6978e28929ad", "id": "b15b2cb1-51f7-453d-b500-ea0a00851eec", "active_ingredient": [ "ACTIVE INGREDIENT TITANIUM DIOXIDE 1.40%" ] }, { "effective_time": "20151106", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Urethritis" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "MAGNESIA SULPHURICA MAGNESIA SULPHURICA MAGNESIUM SULFATE HEPTAHYDRATE MAGNESIUM CATION SUCROSE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "0397bcf5-4708-4ec9-98cb-73dd5b6a3de7", "id": "31c043f5-1d17-49b0-8342-4f585418a48b", "active_ingredient": [ "ACTIVE INGREDIENT MAGNESIA SULPHURICA HPUS 1X and higher" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves joint pains" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bijon 40 (Number 54) Cimicifuga Racemosa, Hypericum Perforatum BLACK COHOSH BLACK COHOSH HYPERICUM PERFORATUM HYPERICUM PERFORATUM SUCROSE LACTOSE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bijon 40 Number 54 Homeopathic Product Cimicifuga racemosa 200C HPUS, Hypericum perforatum 30C HPUS Relieves joint pains Quantity 96 Pills Bijon 40" ], "indications_and_usage": [ "Uses Relieves joint pains" ], "set_id": "03ad2fd2-43ca-3a70-e054-00144ff8d46c", "id": "0fc5de18-b767-427b-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Cimicifuga racemosa 200C HPUS, Hypericum perforatum 30C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves constipation and irregular bowels" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Sisamo 40 (Number 67) Alumina, Bryonia Alba ALUMINUM OXIDE ALUMINUM OXIDE BRYONIA ALBA ROOT BRYONIA ALBA ROOT SUCROSE LACTOSE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Sisamo 40 Number 67 Homeopathic Product Alumina 200C HPUS, Bryonia alba 30C HPUS Relieves constipation and irregular bowels Quantity 96 Pills Sisamo 40" ], "indications_and_usage": [ "Uses Relieves constipation and irregular bowels" ], "set_id": "03e83a82-6e46-3ec0-e054-00144ff88e88", "id": "101685ab-f258-1fa8-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Alumina 200C HPUS, Bryonia alba 30C HPUS" ] }, { "effective_time": "20140630", "inactive_ingredient": [ "INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, CYCLOMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, SORBITAN ISOSTEARATE, TRIBEHENIN, CALCIUM BEHENATE, MELANIN, DIMETHICONOL, ALUMINA, PEG-10 DIMETHICONE, METHICONE, IRON OXIDES, CHOLECALCIFEROL, LYCOPENE, GLYCERIN, SUCROSE PALMITATE, LECITHIN." ], "purpose": [ "PURPOSE SUNSCREEN" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS? CALL 877.423.1314 * WWW.LOVEMYBODY.COM" ], "spl_product_data_elements": [ "CALM IT DOWN KIT TITANIUM DIOXIDE, ZINC OXIDE PROTECT AND SERVE TINTED SUN SHIELD SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE CYCLOMETHICONE 5 CYCLOMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER SORBITAN ISOSTEARATE TRIBEHENIN CALCIUM BEHENATE MELANIN SYNTHETIC (TYROSINE, PEROXIDE) DIMETHICONOL (41 MPA.S) ALUMINUM OXIDE PEG-10 DIMETHICONE (600 CST) METHICONE (20 CST) FERRIC OXIDE RED CHOLECALCIFEROL LYCOPENE GLYCERIN SUCROSE PALMITATE LECITHIN, SOYBEAN CLEAN ROUTINE WATER SODIUM COCOYL GLUTAMATE COCO-BETAINE MYRISTOYL PENTAPEPTIDE-4 CURDLAN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF LIME JUICE COCONUT ACID SAFFLOWER ACID CITRIC ACID MONOHYDRATE GLYCERYL LAURATE LAURIC ACID GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) SUCROSE COCOATE POTASSIUM HYDROXIDE SODIUM BENZOATE CALM AFTER THE STORM WATER GLYCERIN CYCLOMETHICONE 5 BUTYLENE GLYCOL SAFETY BLANKET WATER CETOSTEARYL ALCOHOL STEARYL ALCOHOL POLYSORBATE 60" ], "other_safety_information": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING. DO NOT USE IF INNER SEAL IS BROKEN. SUN ALERT LIMITING SUN EXPOSURE, WEARING PRODUCTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLETAGE. APPLY EVENLY 15-30 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER SWIMMING OR PERSPIRING. FOR BEST RESULTS CLEANSE SKIN THOROUGHLY BEFORE APPLYING. APPLY LIBERALLY TO FACE AND NECK BEFORE SUN EXPOSURE. USE ALONE OR UNDER MAKE-UP. CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR." ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS." ], "do_not_use": [ "DO NOT USE ON INFLAMED OR BROKEN SKIN." ], "package_label_principal_display_panel": [ "CALM IT down_ART_Box_FR CALM IT down_ART_Box_BK CALM IT down_ART_Box_Sleeve" ], "indications_and_usage": [ "USE HELPS PROTECT AGAINST SUNBURN" ], "set_id": "0430bf68-ee36-4762-a245-ec280cb480a5", "id": "10847989-96c6-427a-82d3-1ac9121c4beb", "active_ingredient": [ "ACTIVE INGREDIENT TITANIUM DIOXIDE 10.9% ZINC OXIDE 4.01%" ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium occidentale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. Xerophyllum Asphodeloides Xerophyllum Asphodeloides Aconitum Napellus Aconitum Napellus Anacardium Occidentale Fruit Anacardium Occidentale Fruit Apis Mellifera Apis Mellifera Bryonia Alba Root Bryonia Alba Root Lytta Vesicatoria Lytta Vesicatoria Croton Tiglium Seed Croton Tiglium Seed Graphite Graphite Grindelia Hirsutula Flowering Top Grindelia Hirsutula Flowering Top Daphne Mezereum Bark Daphne Mezereum Bark Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Ranunculus Bulbosus Ranunculus Bulbosus Toxicodendron Pubescens Leaf Toxicodendron Pubescens Leaf Smilax Regelii Root Smilax Regelii Root Echinacea, Unspecified Echinacea, Unspecified Rumex Crispus Root Rumex Crispus Root Taraxacum Officinale Taraxacum Officinale Urtica Urens Urtica Urens Sulfur Sulfur Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Poison Ivy Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering." ], "set_id": "04be40dd-0ec7-00ac-4483-5ad8015e6b80", "id": "dc85be41-7f90-4d68-f98b-b401d3b0c109", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Xerophyllum asphodeloides 30x, Aconitum nap. 15x, Anacardium occidentale 15x, Apis mel. 15x, Bryonia 15x, Cantharis 15x, Croton 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vom. 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x." ] }, { "effective_time": "20121228", "inactive_ingredient": [ "ALSO CONTAINS WATER, ISOHEXADECANE, GLYCERIN, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CYCLOPENTASILOXANE, PEG/PPG-20/20 DIMETHICONE, STEARETH-21, STEARYL ALCOHOL, SUCROSE POLYCOTTONSEEDATE, NIACINAMIDE, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, PANTHENOL, BEHENYL ALCOHOL, DMDM HYDANTOIN, IODOPROPYNYL BUTYLCARBAMATE, TOCOPHERYL ACETATE, CETYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, DISODIUM EDTA, ALOE BARBADENSIS LEAF JUICE, STEARETH-2, OLETH-3 PHOSPHATE, TRIETHOXYCAPRYLYLSILANE." ], "purpose": [ "complete SPF 30 DEFENSE essential care, every day" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "WARNING FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN." ], "when_using": [ "NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER." ], "questions": [ "Questions? 1-800-285-5170" ], "spl_product_data_elements": [ "Olay Complete SPF 30 Defense Daily UV Moisturizer Sensitive Skin Octinoxate, Zinc Oxide, Octisalate, and Octocrylene Octinoxate Octinoxate Zinc Oxide Zinc Oxide Octisalate Octisalate Octocrylene Octocrylene WATER ISOHEXADECANE GLYCERIN C13-14 ISOPARAFFIN LAURETH-7 CYCLOMETHICONE 5 STEARETH-21 STEARYL ALCOHOL NIACINAMIDE PANTHENOL DOCOSANOL DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE CETYL ALCOHOL GREEN TEA LEAF EDETATE DISODIUM ALOE VERA LEAF STEARETH-2 OLETH-3 PHOSPHATE TRIETHOXYCAPRYLYLSILANE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Smooth liberally on face and neck daily as often as necessary. Children under six months of age: consult a doctor." ], "stop_use": [ "DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR." ], "spl_unclassified_section": [ "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 75 mL Carton OLAY ® complete SPF 30 Defense daily UV moisturizer with vitamins E, B3 & pro-vitamin B5 UVA/UVB BROAD SPECTRUM SPF 30 sensitive skin light, non-greasy lotion 2.5 FL OZ (75 mL) Principal Display Panel - 75 mL Carton" ], "indications_and_usage": [ "Gives your skin Olay moisture with vitamins and SPF 30 UV protection in a light, non-greasy formula. For a lifetime of beautiful skin. Moisture light enough to wear every day. UVA/UVB SPF 30 helps prevent premature skin damage. Formula with vitamin E, B3 & pro-vitamin B5 replenishes moisture and absorbs quickly into skin. Light, Non-greasy formula for a barely-there feel. Defend your skin – SPF 30 provides extra UV protection against 97% of the sun's harmful burning rays to help prevent sun damage, so skin stays healthy and younger-looking." ], "set_id": "04c2b169-718b-4330-b76c-57cb44b0a695", "id": "45740019-1963-4d84-a3df-34f36f29d926", "active_ingredient": [ "ACTIVE INGREDIENTS 7.5% OCTINOXATE, 6.0% ZINC OXIDE, 2.5% OCTISALATE, 2.5% OCTOCRYLENE." ] }, { "effective_time": "20110826", "inactive_ingredient": [ "Inactive Ingredients anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children" ], "questions": [ "Questions? Adverse drug event call (888) 933-3222" ], "spl_product_data_elements": [ "Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Citric Acid Monohydrate Sodium Benzoate Glycerin polyethylene glycols sodium citrate sodium chloride" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take every 4 to 6 hours do not take more than 6 doses in 24 hours children under 2 years: do not use children 2 to 5 years: do not use unless directed by a doctor children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information each teaspoon contains: sodium 14 mg store between 20 to 25°C (68 to 77°F) protect from light store in outer carton until contents sused." ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton Children's ALLERGY RELIEF Health Select ® Diphenhydramine HCl Antihistamine For Temporary Relief of: Itchy, Watery Eyes Itchy Throat Runny Nose Sneezing For Ages 12 and Older Alcohol Free NET 4 FL OZ (118 ML) NDC 49743-3001-1 Principal Display Panel" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "04e38dab-16b1-4848-9dcb-92e9f67e6119", "id": "dfcebe7c-7215-47cf-9e2c-9822439eb207", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20150304", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Prevents recurrence of common cold" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Adinos 40 (Number 125) Lycopodium Clavatum, Ipecacuanha LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE LACTOSE IPECAC IPECAC SUCROSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Adinos 40 Number 125 Homeopathic Product Lycopodium clavatum 200C HPUS, Ipecacuanha 200C HPUS Prevents recurrence of common cold Quantity 96 Pills Adinos 40" ], "indications_and_usage": [ "Uses Prevents recurrence of common cold" ], "set_id": "04eb9a32-8eca-06bc-e054-00144ff88e88", "id": "107c6090-9205-571d-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Lycopodium clavatum 200C HPUS, Ipecacuanha 200C HPUS" ] }, { "effective_time": "20090827", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ). Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients ). Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ).", "Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers )." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "0505fe62-ac59-475e-8c94-1933398be580", "id": "30004e84-7a7b-46ac-b6fe-bd1835dd9fcf", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.", "Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients )." ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate CODEINE PHOSPHATE CODEINE PROMETHAZINE HYDROCHLORIDE PROMETHAZINE ALCOHOL ASCORBIC ACID CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181652 R1/09-R4 Relabeling of \"Additional Barcode label\" by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "how_supplied": [ "HOW SUPPLIED Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in: 4 fluid ounce (118 mL) NDC 54868-1029-1 , 8 fluid ounce (237 mL) NDC 54868-1029-0 . and pint (473 mL) NDC 54868-1029-2 ." ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Promethazine with Codeine Syrup This is an image of the label for Promethazine with Codiene Syrup." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames." ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps" ], "spl_product_data_elements": [ "Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Temporary Relief of Occasional Constipation Compare to the Active Ingredient of Ducolax®* Gentle Laxative Bisacodyl Stimulant Laxative 25 Tablets 5 mg each TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF00000 50844 REV0510B32765 Our Family 44-327-56 Product Label" ], "indications_and_usage": [ "Use(s) relieves occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "050780d6-b1bd-4717-b517-527b86bb9dfa", "id": "aa329d94-d60c-4a9b-aebd-d707ba6bedb1", "active_ingredient": [ "Active ingredient Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20150304", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals post operative wounds faster" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bishala 40 (Number 136) Hypericum perforatum, Arnica montana HYPERICUM PERFORATUM HYPERICUM PERFORATUM ARNICA MONTANA ARNICA MONTANA SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bishala 40 Number 136 Homeopathic Product Hypericum perforatum 30C HPUS, Arnica montana 30C HPUS Heals post operative wounds faster Quantity 96 Pills Bishala 40" ], "indications_and_usage": [ "Uses Heals post operative wounds faster" ], "set_id": "0514156a-417e-694d-e054-00144ff88e88", "id": "107c6090-9212-571d-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Hypericum perforatum 30C HPUS, Arnica montana 30C HPUS" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve menstrual irregularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Badispen 40 (Number 75) Caulophyllum thalictroides, Secale cornutum CAULOPHYLLUM THALICTROIDES ROOT CAULOPHYLLUM THALICTROIDES ROOT CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Badispen 40 Number 75 Homeopathic Product Caulophyllum thalictroides 200C HPUS, Secale cornutum 30C HPUS Helps improve menstrual irregularity Quantity 96 Pills Badispen 40" ], "indications_and_usage": [ "Uses Helps improve menstrual irregularity" ], "set_id": "051654e9-8326-14e6-e054-00144ff88e88", "id": "0fc4a4b2-3431-5948-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Caulophyllum thalictroides 200C HPUS, Secale cornutum 30C HPUS" ] }, { "effective_time": "20141007", "inactive_ingredient": [ "Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "purpose": [ "Uses Helps prevent Sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun. Keep out of reach of children. If product is swallowed, get medical help contact a Poison Control Center right away. Stop use and ask a dcotor if rash occurs. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help contact a Poison Control Center right away. Stop use and ask a dcotor if rash occurs. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "spl_product_data_elements": [ "Time Frame Future Resist Foundation Broad Spectrum SPF 20 Delilah Cosmetics Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE ISONONYL ISONONANOATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) PHENYL TRIMETHICONE C12-15 ALKYL BENZOATE DISTEARDIMONIUM HECTORITE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE SODIUM CHLORIDE ALUMINUM OXIDE SODIUM DEHYDROACETATE METHICONE (20 CST) TRIETHOXYCAPRYLYLSILANE MEDIUM-CHAIN TRIGLYCERIDES TRISODIUM ETHYLENEDIAMINE DISUCCINATE DIMETHICONE TROPOLONE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "package_label_principal_display_panel": [ "Delilah Time Frame Future Resist Foundation Broad Spectrum SPF 20 Fond de Teint SPF 20 Anti Vieilssement secondary primary" ], "indications_and_usage": [ "Stop use and ask a dcotor if rash occurs. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ], "set_id": "051ae534-1f0e-4b60-82db-d2ac4316608c", "id": "4ca66249-7358-40b6-9ca8-778752bc2663", "active_ingredient": [ "Active Ingredients Purpose Titanium Dioxide 5% Sunscreen Uses Helps prevent Sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun. Keep out of reach of children. If product is swallowed, get medical help contact a Poison Control Center right away. Stop use and ask a dcotor if rash occurs. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Directions Apply foundation liberally to clean face for Broad Spectrum protection. Reapply as needed. This is not a primary Sunscreen. For further protection by a primary Sunscreen follow directions below. Apply primary Sunscreen liberally 15 minutes before sun exposure Reapply at least every 2 hours. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months ask doctor Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-4, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides)." ] }, { "spl_product_data_elements": [ "Candida parapsilosis CANDIDA PARAPSILOSIS CANDIDA PARAPSILOSIS CANDIDA PARAPSILOSIS SUCROSE LACTOSE white" ], "active_ingredient": [ "ACTIVE INGREDIENTS CANDIDA PARAP" ], "purpose": [ "USES To relieve the symptoms of fungus." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children." ], "indications_and_usage": [ "INDICATIONS Indications: CANDIDA PARAP Fungus" ], "warnings": [ "STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner." ], "dosage_and_administration": [ "DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose/Lactose" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL The OTC potency range of CANDIDA PARAP is 12x–30x, 6c–30c, 200c, 1m, 10m, 50m, and CM. Availability is subject to change. All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled. ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice. Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. Candida parap label example" ], "set_id": "05728cf8-3a7e-4dec-b903-f3575571db59", "id": "2e423525-e444-42ff-9157-f5535e05380a", "effective_time": "20130201", "version": "1", "openfda": {} }, { "effective_time": "20150304", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Prevents severe hair loss" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Chulin 40 (Number 546) Graphites, Lycopodium Clavatum GRAPHITE GRAPHITE LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Chulin 40 Number 546 Homeopathic Product Graphites 30C HPUS, Lycopodium clavatum 30C HPUS Prevents severe hair loss Quantity 96 Pills Chulin 40" ], "indications_and_usage": [ "Uses Prevents severe hair loss" ], "set_id": "05906f8e-ed75-0145-e054-00144ff88e88", "id": "107ce18f-17b0-6f77-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Graphites 30C HPUS, Lycopodium clavatum 30C HPUS" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Prevents recurrence of piles" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Conpil 40 (Number 510) Conium maculatum, Nux vomica CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Conpil 40 Number 510 Homeopathic Product Conium maculatum 30C HPUS, Nux vomica 200C HPUS Prevents recurrence of piles Quantity 96 Pills Conpil 40" ], "indications_and_usage": [ "Uses Prevents recurrence of piles" ], "set_id": "05a2d47a-7f11-36ad-e054-00144ff88e88", "id": "0fc60597-a441-1a0f-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Conium maculatum 30C HPUS, Nux vomica 200C HPUS" ] }, { "effective_time": "20141017", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves loose motions and diarrhea" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Dirin 40 (Number 68) Argentum nitricum, Pulsatilla nigricans PULSATILLA PRATENSIS PULSATILLA PRATENSIS SILVER NITRATE SILVER CATION SUCROSE LACTOSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Dirin 40 Number 68 Homeopathic Product Argentum Nitricum 30C HPUS, Pulsatilla Nigricans 30C HPUS Relieves loose motions and diarrhea Quantity 96 Pills Dirin 40" ], "indications_and_usage": [ "Uses Relieves loose motions and diarrhea" ], "set_id": "05a2d47a-7f22-36ad-e054-00144ff88e88", "id": "05a2d47a-7f23-36ad-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Argentum Nitricum 30C HPUS, Pulsatilla Nigricans 30C HPUS" ] }, { "effective_time": "20140127", "inactive_ingredient": [ "Inactive Ingredients: purified water, natural flavors, liquid sucrose, citric acid, xanthan gum, luo han guo concentrate" ], "purpose": [ "Concentrated Liquid Shot NicFix+ For when you CAN'T SMOKE... or CHOOSE not to. Minty Mojito 2 fl. oz. (59 mL)" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Suggested Use: 18 years of age or older" ], "warnings": [ "Warning: do not use if you are prenant or lactating or have phenylketonuria. Consult your doctor or health care professional before us if you are taking prescription medication for depression such as MAO inhibitors or have asthma, high blood pressure, stomach ulcers, diabetes, or hyperthyroidism. Nicotine or caffeine can increase your heart rate. This product contains nicotine, a chemical known to the state of California to cause birth defects or other reproductive harms. Caution : For any suspected or known illness or dysfunction, always consult your physician or medical adviser first." ], "spl_product_data_elements": [ "NicFix Plus Nicotine NICOTINE NICOTINE TYROSINE TYROSINE PHENYLALANINE PHENYLALANINE CAFFEINE CAFFEINE CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID SUCRALOSE SODIUM BENZOATE WATER XANTHAN GUM SIRAITIA GROSVENORII FRUIT" ], "other_safety_information": [ "ONCE OPENED USE WITHIN 48 HOURS Patented process NDC 42638-7685-2 Distributed by Nico Worldwide, Inc. NicFix is a product of Nico Worldwide, Inc. 320 Irving Dr., Oxnard, CA 93030 www.nicoworldwide.com" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "SAFE TO USE WHILE SMOKING Directions: Use as required. Do not use nicotine cessation products while using this product. Homeopathic Nicotinum Complex. Registeres as a homeopathic remedy. www.getyournicfix.com" ], "package_label_principal_display_panel": [ "label image" ], "indications_and_usage": [ "REFRIGERATE AFTER OPENING Indications: Use when smoking is not allowed or when you should not smoke. Recommended for morning and early afternoon use." ], "set_id": "05d5761b-738f-46fa-833c-97901d1164de", "id": "620e053b-22c4-422b-b16a-3093e0601f6e", "active_ingredient": [ "Ingredients: SNRA (Nicotinum 6X) In a base of: buffered caffeine anhydrous, L-tyrosine, L-phenylalanine" ] }, { "effective_time": "20150907", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Cold With Chills" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "ARANEA DIADEMA ARANEA DIADEMA ARANEUS DIADEMATUS ARANEUS DIADEMATUS SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "05ebcbb7-704d-4fa7-baa7-a0c0d8648967", "id": "8c364bde-aad8-4122-9bf4-339acaec371a", "active_ingredient": [ "ACTIVE INGREDIENT ARANEA DIADEMA HPUS 2X and higher" ] }, { "effective_time": "20141021", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves toothache" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Danton 40 (Number 62) Mezereum, Atropa belladonaa DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK LACTOSE ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Danton 40 Number 62 Homeopathic Product Mezereum 6C HPUS, Atropa Belladonna 30C HPUS Relieves toothache Quantity 96 Pills Danton 40" ], "indications_and_usage": [ "Uses Relieves toothache" ], "set_id": "05efd4b8-5b5f-1aeb-e054-00144ff88e88", "id": "05efd4b8-5b60-1aeb-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Mezereum 6C HPUS, Atropa Belladonna 30C HPUS" ] }, { "effective_time": "20150225", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals throat infection with difficulty in swallowing" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Disfas 40 (Number 59) Phytolacca, Belladonna ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE LACTOSE PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Disfas 40 Number 59 Homeopathic Product Phytolacca 30C HPUS, Belladonna 30C HPUS Heals throat infection with difficulty in swallowing Quantity 96 Pills Disfas 40" ], "indications_and_usage": [ "Uses Heals throat infection with difficulty in swallowing" ], "set_id": "0602f1c6-b32e-00d2-e054-00144ff88e88", "id": "0fe190a6-94ad-2b86-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Phytolacca 30C HPUS, Belladonna 30C HPUS" ] }, { "effective_time": "20150225", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves backache from spondylosis" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Disprol 40 (Number 51) Bryonia Alba, Cimicifuga Racemosa BRYONIA ALBA ROOT BRYONIA ALBA ROOT BLACK COHOSH BLACK COHOSH SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Disprol 40 Number 51 Homeopathic Product Bryonia alba 30C HPUS, Cimicifuga racemosa 200C HPUS Relieves backache from spondylosis Quantity 96 Pills Disprol 40" ], "indications_and_usage": [ "Uses Relieves backache from spondylosis" ], "set_id": "06195cfa-f819-2298-e054-00144ff88e88", "id": "0fee47d8-2e27-44c1-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Bryonia alba 30C HPUS, Cimicifuga racemosa 200C HPUS" ] }, { "effective_time": "20150304", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Treats amenorrhea or menstrual irregularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Eutopa 40 (Number 553 Sepia, Aurum Metallicum SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE GOLD GOLD SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Eutopa 40 Number 553 Homeopathic Product Sepia 6C HPUS, Aurum metallicum 30C HPUS Treats amenorrhea or menstrual irregularity Quantity 96 Pills Eutopa 40" ], "indications_and_usage": [ "Uses Treats amenorrhea or menstrual irregularity" ], "set_id": "061acc74-eb3f-6887-e054-00144ff8d46c", "id": "107bdf31-31aa-44c7-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Sepia 6C HPUS, Aurum metallicum 30C HPUS" ] }, { "effective_time": "20141023", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Treats profuse protracted menses with mainly liquid blood" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Fludblid 40 (Number 143) Cimicifuga Racemosa, Bovista BLACK COHOSH BLACK COHOSH LYCOPERDON UTRIFORME FRUITING BODY LYCOPERDON UTRIFORME FRUITING BODY SUCROSE LACTOSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Fludblid 40 Number 143 Homeopathic Product Cimicifuga Racemosa 200C HPUS, Bovista 30C HPUS Treats profuse protracted menses with mainly liquid blood Quantity 96 Pills Fludblid 40" ], "indications_and_usage": [ "Uses Treats profuse protracted menses with mainly liquid blood" ], "set_id": "061acc74-eb52-6887-e054-00144ff8d46c", "id": "061acc74-eb53-6887-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Cimicifuga Racemosa 200C HPUS, Bovista 30C HPUS" ] }, { "effective_time": "20150302", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves persistent nocturnal cough & insomnia" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Ghumer 40 (Number 47) Hyoscyamus Niger, Aurum Metallicum SUCROSE LACTOSE HYOSCYAMUS NIGER HYOSCYAMUS NIGER GOLD GOLD" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Ghumer 40 Number 47 Homeopathic Product Hyoscyamus niger 6C HPUS, Aurum metallicum 30C HPUS Relieves persistent nocturnal cough & insomnia Quantity 96 Pills Ghumer 40" ], "indications_and_usage": [ "Uses Relieves persistent nocturnal cough & insomnia" ], "set_id": "061c423d-6f35-2e4d-e054-00144ff8d46c", "id": "104fd887-18dc-5395-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Hyoscyamus niger 6C HPUS, Aurum metallicum 30C HPUS" ] }, { "effective_time": "20141023", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves flatulence and bloated feeling in abdomen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Gallchi 40 (Number 556) Nux Vomica, Cinchona Officinalis SUCROSE LACTOSE CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Gallchi 40 Number 556 Homeopathic Product Nux Vomica 200C HPUS, Cinchona Officinalis 6C HPUS Relieves flatulence and bloated feeling in abdomen Quantity 96 Pills Gallchi 40" ], "indications_and_usage": [ "Uses Relieves flatulence and bloated feeling in abdomen" ], "set_id": "061d3abf-6af5-2043-e054-00144ff88e88", "id": "061d3abf-6af6-2043-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Nux Vomica 200C HPUS, Cinchona Officinalis 6C HPUS" ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves pain in hip and lower abdomen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Gallkid 40 (Number 92) Sarsaparilla, Tabacum SUCROSE LACTOSE SMILAX REGELII ROOT SMILAX REGELII ROOT TOBACCO LEAF TOBACCO LEAF" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Gallkid 40 Number 92 Homeopathic Product Sarsaparilla 200C HPUS, Tabacum 30C HPUS Relieves pain in hip and lower abdomen Quantity 96 Pills Gallkid 40" ], "indications_and_usage": [ "Uses Relieves pain in hip and lower abdomen" ], "set_id": "062a3310-9e57-04e8-e054-00144ff88e88", "id": "10d96ae3-3407-50b2-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Sarsaparilla 200C HPUS, Tabacum 30C HPUS" ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve profuse menses and bleeding piles" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Hemorin 40 (Number 63) Millefolium, Arnica Montana ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM ARNICA MONTANA ARNICA MONTANA SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Hemorin 40 Number 63 Homeopathic Product Millefolium 6C HPUS, Arnica montana 200C HPUS Helps improve profuse menses and bleeding piles Quantity 96 Pills Hemorin 40" ], "indications_and_usage": [ "Uses Helps improve profuse menses and bleeding piles" ], "set_id": "062e78dc-1494-22e4-e054-00144ff88e88", "id": "10d96ae3-340d-50b2-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Millefolium 6C HPUS, Arnica montana 200C HPUS" ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve tinnitus in the ear with vertigo" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Kanmet 40 (Number 615) Chamomilla, Belladonna LACTOSE SUCROSE MATRICARIA RECUTITA MATRICARIA RECUTITA ATROPA BELLADONNA ATROPA BELLADONNA" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Kanmet 40 Number 615 Homeopathic Product Chamomilla 200C HPUS, Belladonna 30C HPUS Helps improve tinnitus in the ear with vertigo Quantity 96 Pills Kanmet 40" ], "indications_and_usage": [ "Uses Helps improve tinnitus in the ear with vertigo" ], "set_id": "063122d3-497c-023d-e054-00144ff8d46c", "id": "10d96ae3-3412-50b2-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Chamomilla 200C HPUS, Belladonna 30C HPUS" ] }, { "effective_time": "20151113", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Painful Limb Cramps" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children" ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "PLUMBUM ACETICUM PLUMBUM ACETICUM LEAD ACETATE ANHYDROUS LEAD IODIDE SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "063eb9b1-a03a-45d3-9d57-42be0c1f6b24", "id": "09ed1b70-f032-45aa-a7e3-54ad7ba2b14c", "active_ingredient": [ "ACTIVE INGREDIENT PLUMBUM ACETICUM HPUS 1X and higher" ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana Angelica Sinensis Root Angelica Sinensis Root Arsenic Trioxide Arsenic Cation (3+) Bryonia Alba Root Bryonia Alba Root Caulophyllum Thalictroides Root Caulophyllum Thalictroides Root Black Cohosh Black Cohosh Cinchona Officinalis Bark Cinchona Officinalis Bark Dioscorea Villosa Tuber Dioscorea Villosa Tuber Estrone Estrone Gelsemium Sempervirens Root Gelsemium Sempervirens Root Lachesis Muta Venom Lachesis Muta Venom Lilium Lancifolium Whole Flowering Lilium Lancifolium Whole Flowering Lycopodium Clavatum Spore Lycopodium Clavatum Spore Achillea Millefolium Achillea Millefolium Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Pulsatilla Vulgaris Pulsatilla Vulgaris Juniperus Sabina Leafy Twig Juniperus Sabina Leafy Twig Claviceps Purpurea Sclerotium Claviceps Purpurea Sclerotium Sepia Officinalis Juice Sepia Officinalis Juice Capsella Bursa-pastoris Capsella Bursa-pastoris Viburnum Opulus Bark Viburnum Opulus Bark Ginger Ginger Echinacea, Unspecified Echinacea, Unspecified Valerian Valerian Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets orally as needed or as directed by a healthcare professional." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Menstrual - PMS Formulated for associated symptoms such as irregularity, cramping, bloating, headache, cravings, emotional upsets and mood swings." ], "set_id": "064db435-6737-75ab-b84a-7590d5dbf99d", "id": "2d662d2e-30a9-46c5-6b6e-9159fb909215", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Angelica sinensis radix 20x, Arsenicum alb. 20x, Bryonia 20x, Caulophyllum 20x, Cimicifuga 20x, Cinchona 20x, Dioscorea 20x, Folliculinum 20x, Gelsemium 20x, Lachesis 20x, Lilium 20x, Lycopodium 20x, Millefolium 20x, Nux vom. 20x, Pulsatilla 20x, Sabina 20x, Secale 20x, Sepia 20x, Thlaspi 20x, Viburnum op. 20x, Zingiber 20x, Dioscorea 8x, Echinacea 8x, Valeriana 8x, Dioscorea 3x, Echinacea 3x, Valeriana 3x." ] }, { "effective_time": "20150228", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Prevents recurrent mouth ulcers" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Moutal 40 (Number 60) Calcarea sulphurica, Arsenicum album CALCIUM SULFATE ANHYDROUS CALCIUM CATION ARSENIC TRIOXIDE ARSENIC CATION (3+) SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Moutal 40 Number 60 Homeopathic Product Calcarea sulphurica 30C HPUS, Arsenicum album 30C HPUS Prevents recurrent mouth ulcers Quantity 96 Pills Moutal 40" ], "indications_and_usage": [ "Uses Prevents recurrent mouth ulcers" ], "set_id": "0666d58a-280b-06e5-e054-00144ff88e88", "id": "10252d90-57d1-2151-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Calcarea sulphurica 30C HPUS, Arsenicum album 30C HPUS" ] }, { "effective_time": "20150228", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves headache - mainly forehead" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Sirpa 40 (Number 76) Rhus Toxicodendron, Atropa Belladonna TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Sirpa 40 Number 76 Homeopathic Product Rhus toxicodendron 200C HPUS, Belladonna 30C HPUS Relieves headache - mainly forehead Quantity 96 Pills Sirpa 40" ], "indications_and_usage": [ "Uses Relieves headache - mainly forehead" ], "set_id": "066e20dc-0e69-3784-e054-00144ff8d46c", "id": "101e6d53-3df0-0d79-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Rhus toxicodendron 200C HPUS, Belladonna 30C HPUS" ] }, { "effective_time": "20150929", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve abnormal mental irritability" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Trigon 40 (Number 507) Belladonna, Ignatia amara ATROPA BELLADONNA ATROPA BELLADONNA STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED SUCROSE LACTOSE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Trigon 40 Number 507 Homeopathic Product Belladonna 200C, Ignatia amara 30C HPUS Helps improve abnormal mental irritability Quantity 96 Pills Trigon 40" ], "indications_and_usage": [ "Uses Helps improve abnormal mental irritability" ], "set_id": "0679f8de-a465-1c14-e054-00144ff88e88", "id": "20e0739a-31a0-3af2-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Belladonna 200C HPUS, Ignatia amara 30C HPUS" ] }, { "effective_time": "20150302", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves tropical fever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Jarin 40 (Number 571) Belladonna, Bryonia alba ATROPA BELLADONNA ATROPA BELLADONNA BRYONIA ALBA ROOT BRYONIA ALBA ROOT SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Jarin 40 Number 571 Homeopathic Product Belladonna 30C HPUS, Bryonia alba 30C HPUS Relieves tropical fever Quantity 96 Pills Jarin 40" ], "indications_and_usage": [ "Uses Relieves tropical fever" ], "set_id": "0679f8de-a468-1c14-e054-00144ff88e88", "id": "10525646-c9e2-3d01-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Belladonna 30C HPUS, Bryonia alba 30C HPUS" ] }, { "effective_time": "20150307", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Treats watery diarrhea" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Ames 40 (Number 527) Veratrum Album, Mercurius Solubilis SUCROSE LACTOSE VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Ames 40 Number 527 Homeopathic Product Veratrum album 30C HPUS, Mercurius solubilis 6C HPUS Treats watery diarrhea Quantity 96 Pills Ames 40" ], "indications_and_usage": [ "Uses Treats watery diarrhea" ], "set_id": "067d9633-bdb1-3df0-e054-00144ff8d46c", "id": "10b26246-cbe3-274e-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Veratrum album 30C HPUS, Mercurius solubilis 6C HPUS" ] }, { "effective_time": "20150210", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves nausea after taking food" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Poisthum 40 (Number 93) Ipecacuanha, Bismuthum Subnitricum IPECAC IPECAC BISMUTH SUBNITRATE BISMUTH CATION SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Poisthum 40 Number 93 Homeopathic Product Ipecacuanha 200C HPUS, Bismuthum subnitricum 6C HPUS Relieves nausea after taking food Quantity 96 Pills Poisthum 40" ], "indications_and_usage": [ "Uses Relieves nausea after taking food" ], "set_id": "067f9f73-8625-5fc5-e054-00144ff88e88", "id": "0ec08d51-87ac-5bcd-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Ipecacuanha 200C HPUS, Bismuthum subnitricum 6C HPUS" ] }, { "effective_time": "20150209", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve obstructive amenorrhea" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Ameno 40 (Number 614) Sepia, Bryonia Alba SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE BRYONIA ALBA ROOT BRYONIA ALBA ROOT SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Ameno 40 Number 614 Homeopathic Product Sepia 200C HPUS, Bryonia alba 30C HPUS Helps improve obstructive amenorrhea Quantity 96 Pills Ameno 40" ], "indications_and_usage": [ "Uses Helps improve obstructive amenorrhea" ], "set_id": "0680c1b9-449b-142d-e054-00144ff88e88", "id": "0eabe839-c58d-669c-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Sepia 200C HPUS, Bryonia alba 30C HPUS" ] }, { "effective_time": "20141029", "inactive_ingredient": [ "Water, Caprylic Capric Triglyceride,Glycerin, Isoamyl Laurate, Coconut Alkanes, Polyglyceryl-2 Sesquioleate, Polyglyceryl-3 Ricinoleate, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Brassica Oleracea Acephala Leaf Extract, Elettaria Cardamomum Seed Extract, Ribes Nigrum (Blackcurrant) Leaf Extract, Rubus Idaeus (Raspberry) Leaf Extract, Spinacia Oleracea (Spinach) Leaf Extract, Garcinia Indica Seed Butter, Ascorbyl Glucoside, Biosaccharide Gum-1, Bisabolol, Retinyl Palmitate,Sucrose, Tapioca Starch,Lavandula Angusiofolia (Lavender) Oil, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Beta Vulgaris (Beet)Root Extract, Alumina, Calcium Ascorbate, Coco-Caprylate/Caprate ,Xanthophyl,Glyceryl Caprylate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Sodium Anisate, Sodium Lavulinate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba Good and Healthy Moisturizer SPF15 Zinc Oxide, Titanium Dioxide RUBUS IDAEUS LEAF RIBES NIGRUM LEAF STARCH, TAPIOCA CARDAMOM ASCORBYL GLUCOSIDE BIOSACCHARIDE GUM-1 LEVOMENOL VITAMIN A PALMITATE SUCROSE LUTEIN BETA VULGARIS CALCIUM ASCORBATE ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF ISOAMYL LAURATE COCONUT ALKANES GLYCERIN POLYGLYCERYL-3 RICINOLEATE WATER SHEA BUTTER ALUMINUM OXIDE COCO-CAPRYLATE/CAPRATE MAGNESIUM SULFATE SODIUM CHLORIDE SORBITAN SESQUIOLEATE STEARIC ACID ECHINACEA PURPUREA ROOT POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE GARCINIA INDICA SEED BUTTER GLYCERYL CAPRYLATE SORBIC ACID KALE SODIUM ANISATE SODIUM LEVULINATE LAVENDER OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Cream.For sunscreen use apply liberall yafter cleansing and 15 minutes before sun exposure.Remove safety seal under cup prior to first use. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating" ], "package_label_principal_display_panel": [ "tube label carton label" ], "indications_and_usage": [ "Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "06840628-9ec2-04f7-e054-00144ff88e88", "id": "06840628-9ec3-04f7-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Zinc Oxide 4.8% Titanium Dioxide 3.7%" ] }, { "effective_time": "20150210", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Prevents hair fall and premature graying" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Npto 40 (Number 120) Arnica Montana, Graphites ARNICA MONTANA ARNICA MONTANA GRAPHITE GRAPHITE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Npto 40 Number 120 Homeopathic Product Arnica montana 30C HPUS, Graphites 30C HPUS Prevents hair fall and premature graying Quantity 96 Pills Npto 40" ], "indications_and_usage": [ "Uses Prevents hair fall and premature graying" ], "set_id": "0691705e-371e-73d3-e054-00144ff8d46c", "id": "0ec08d51-87bc-5bcd-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Arnica montana 30C HPUS, Graphites 30C HPUS" ] }, { "effective_time": "20150209", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals dryness of skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bacnos 40 (Number 501) Mezereum, Graphites GRAPHITE GRAPHITE LACTOSE DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK SUCROSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bacnos 40 Number 501 Homeopathic Product Mezereum 200C HPUS, Graphites 30C HPUS Heals dryness of skin Quantity 96 Pills Bacnos 40" ], "indications_and_usage": [ "Uses Heals dryness of skin" ], "set_id": "0693e472-47bb-559f-e054-00144ff8d46c", "id": "0eace184-f5a6-5d21-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Mezereum 200C HPUS, Graphites 30C HPUS" ] }, { "effective_time": "20150302", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Treats bony growth and bony exostosis" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bontu 40 (Number 537) Arnica montana, Calcarea phosphorica SUCROSE TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION ARNICA MONTANA ARNICA MONTANA LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bontu 40 Number 537 Homeopathic Product Arnica montana 30C HPUS, Calcarea phosphorica 30C HPUS Treats bony growth and bony exostosis Quantity 96 Pills Bontu 40" ], "indications_and_usage": [ "Uses Treats bony growth and bony exostosis" ], "set_id": "06a193cb-3643-26db-e054-00144ff8d46c", "id": "1051948c-fb4a-5447-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Arnica montana 30C HPUS, Calcarea phosphorica 30C HPUS" ] }, { "effective_time": "20150209", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves motion sickness and nausea" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Birin 40 (Number 79) Bismuthum, Arsenicum album ARSENIC TRIOXIDE ARSENIC CATION (3+) BISMUTH SUBNITRATE BISMUTH CATION SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Birin 40 Number 79 Homeopathic Product Bismuthum subnitricum 200C HPUS, Arsenicum album 200C HPUS Relieves motion sickness and nausea Quantity 96 Pills Birin 40" ], "indications_and_usage": [ "Uses Relieves motion sickness and nausea" ], "set_id": "06a389b3-d9cc-5a0d-e054-00144ff8d46c", "id": "0eace184-f5ac-5d21-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Bismuthum subnitricum 200C HPUS, Arsenicum album 200C HPUS" ] }, { "effective_time": "20150512", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals cuts & bruises, useful for all kinds of injuries, pains & sprain relief" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Arnica Montana 3C Arnica Montana ARNICA MONTANA ARNICA MONTANA SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Arnica Montana 3C Homeopathic Product Heals cuts & bruises, useful for all kinds of injuries, pains & sprain relief Quantity 96 Pills Arnica montana 3c" ], "indications_and_usage": [ "Uses Heals cuts & bruises, useful for all kinds of injuries, pains & sprain relief" ], "set_id": "06a73426-7111-5d7e-e054-00144ff88e88", "id": "15e3067c-a49f-6edd-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Arnica Montana 3C HPUS" ] }, { "effective_time": "20101206", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose/Lactose" ], "purpose": [ "USES To relieve the symptoms of wounds." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children." ], "warnings": [ "STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner." ], "spl_product_data_elements": [ "Calendula Officinalis Kit Refill CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP SUCROSE LACTOSE white" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Enter section text here image of vial/card" ], "indications_and_usage": [ "INDICATIONS Indications: CALENDULA OFFICINALIS Wounds" ], "set_id": "06cd6d21-b5f2-4b3b-8479-e6e540606774", "id": "adbefdd1-7dab-4c53-be4b-2a0b66f93031", "active_ingredient": [ "ACTIVE INGREDIENTS CALENDULA OFFICINALIS 200C" ] }, { "effective_time": "20120710", "purpose": [ "Active ingredients (in each lozenge) Purpose Benzocaine 4 mg Oral pain reliever Menthol 9 mg Oral pain reliever" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage." ], "questions": [ "Questions? Call 1-888-963-3382 You may also report side effects to this phone number." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing. store at room temperature 20-25°C (68-77°F) protect contents from humidity" ], "indications_and_usage": [ "Uses temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores" ], "set_id": "06f48907-8469-4f2f-a8f3-3fb3a89fcbc1", "id": "9f118028-0602-4bb1-aeaa-caa7ed567285", "active_ingredient": [ "Active ingredients (in each lozenge) Purpose Benzocaine 4 mg Oral pain reliever Menthol 9 mg Oral pain reliever" ], "inactive_ingredient": [ "Inactive ingredients FD&C blue #1, flavors, glucose, purified water, sodium bicarbonate, sorbitol, sucrose" ], "warnings": [ "Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use in a child under 5 years of age. Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage." ], "spl_product_data_elements": [ "Cepacol Sensations Cooling Benzocaine and Menthol Benzocaine Benzocaine Menthol Menthol FD&C blue no. 1 dextrose water sodium bicarbonate sorbitol sucrose S" ], "ask_doctor": [ "Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops" ], "do_not_use": [ "Do not use in a child under 5 years of age." ], "active_ingredient_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 4 mg Oral pain reliever
Menthol 9 mg Oral pain reliever
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 20 Lozenges Carton NDC 63824-761-20 1 LOZENGE EVERY 2 hours new! Cēpacol ® Sensations™ COOLING Benzocaine 4 mg, Menthol 9 mg – Oral Pain Reliever ‣ Relieves Sore Throat Pain ‣ Instant Cooling Comfort 20 Lozenges ice cool PRINCIPAL DISPLAY PANEL - 20 Lozenges Carton" ], "purpose_table": [ "
Active ingredients (in each lozenge) Purpose
Benzocaine 4 mg Oral pain reliever
Menthol 9 mg Oral pain reliever
" ] }, { "effective_time": "20150207", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves throbbing temporal headache" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bedin 40 (Number 13) Thuja Occidentalis, Belladonna SUCROSE THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG ATROPA BELLADONNA ATROPA BELLADONNA LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bedin 40 Number 13 Homeopathic Product Thuja occidentalis 200C HPUS, Belladonna 3C HPUS Relieves throbbing temporal headache Quantity 96 Pills Bedin 40" ], "indications_and_usage": [ "Uses Relieves throbbing temporal headache" ], "set_id": "06f9a4fe-016b-14e1-e054-00144ff88e88", "id": "0e802d55-51a7-6417-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Thuja occidentalis 200C HPUS, Belladonna 3C HPUS" ] }, { "effective_time": "20150220", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves post menopausal symptoms and headache" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Amhed 40 (Number 72) Atropa Belladonna, Sepia ATROPA BELLADONNA ATROPA BELLADONNA SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Amhed 40 Number 72 Homeopathic Product Belladonna 200C HPUS, Sepia 200C HPUS Relieves post menopausal symptoms and headache Quantity 96 Pills Amhed 40" ], "indications_and_usage": [ "Uses Relieves post menopausal symptoms and headache" ], "set_id": "06fb3ad3-3f96-354d-e054-00144ff8d46c", "id": "0f88a46a-848b-3f5b-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Belladonna 200C HPUS, Sepia 200C HPUS" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves nausea, cough and cold" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Baman 40 (Number 50) Chelidonium Majus, Aethusa Cynapium CHELIDONIUM MAJUS CHELIDONIUM MAJUS AETHUSA CYNAPIUM AETHUSA CYNAPIUM SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Baman 40 Number 50 Homeopathic Product Chelidonium majus 200C HPUS, Aethusa cynapium 30C HPUS Relieves nausea, cough and cold Quantity 96 Pills Baman 40" ], "indications_and_usage": [ "Uses Relieves nausea, cough and cold" ], "set_id": "070aa9bc-84e3-6ed7-e054-00144ff88e88", "id": "0fc6cad0-13dc-6aa9-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Chelidonium majus 200C HPUS, Aethusa cynapium 30C HPUS" ] }, { "effective_time": "20150228", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves earache" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Biracktam 40 (Number 29) Atropa Belladonna, Pulsatilla Nigricans PULSATILLA PRATENSIS PULSATILLA PRATENSIS LACTOSE ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Biracktam 40 Number 29 Homeopathic Product Belladonna 200C HPUS, Pulsatilla nigricans 30C HPUS Relieves earache Quantity 96 Pills Biracktam 40" ], "indications_and_usage": [ "Uses Relieves earache" ], "set_id": "070b7c1b-86f9-163a-e054-00144ff88e88", "id": "1023b43f-1b11-0eae-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Belladonna 200C HPUS, Pulsatilla nigricans 30C HPUS" ] }, { "effective_time": "20150228", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves constipation" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Bulb 40 (Number 17) Calcarea Carbonica, Ledum Palustre OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE LACTOSE LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG SUCROSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Bulb 40 Number 17 Homeopathic Product Calcarea carbonica 200C HPUS, Ledum palustre 30C HPUS Relieves constipation Quantity 96 Pills Bulb 40" ], "indications_and_usage": [ "Uses Relieves constipation" ], "set_id": "070bac62-2771-5f0d-e054-00144ff8d46c", "id": "1023b43f-1b1b-0eae-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Calcarea carbonica 200C HPUS, Ledum palustre 30C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves breathing distress with cough" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Inkar 40 (Number 107) Blatta Orientalis, Ipecacuanha BLATTA ORIENTALIS BLATTA ORIENTALIS IPECAC IPECAC SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Inkar 40 Number 107 Homeopathic Product Blatta orientalis 30C HPUS, Ipecacuanha 200C HPUS Relieves breathing distress with cough Quantity 96 Pills Inkar 40" ], "indications_and_usage": [ "Uses Relieves breathing distress with cough" ], "set_id": "070c6f25-4e8a-3466-e054-00144ff88e88", "id": "100f7e6f-d030-3dda-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Blatta orientalis 30C HPUS, Ipecacuanha 200C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals leukorrhea" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Lukis 40 (Number 53) Arsenicum album, Cimicifuga SUCROSE LACTOSE ARSENIC TRIOXIDE ARSENIC CATION (3+) BLACK COHOSH BLACK COHOSH" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Lukis 40 Number 53 Homeopathic Product Arsenicum album 30C HPUS, Cimicifuga racemosa 200C HPUS Heals leukorrhea Quantity 96 Pills Lukis 40" ], "indications_and_usage": [ "Uses Heals leukorrhea" ], "set_id": "07550725-52e3-23f5-e054-00144ff8d46c", "id": "100fd768-503e-06e6-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Arsenicum album 30C HPUS, Cimicifuga racemosa 200C HPUS" ] }, { "effective_time": "20110929", "inactive_ingredient": [ "Inactive Ingredient: Lactose and Sucrose. Free from yeast, wheat, corn and soy." ], "purpose": [ "WOUNDS, CUTS, MINOR BURNS, OR OTHER INDICATIONS" ], "keep_out_of_reach_of_children": [ "WARNING: Keep this and all medications out of reach of children." ], "warnings": [ "WARNING: Use only if cap and seal are unbroken. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area." ], "questions": [ "Questions or comments .(877)REM4YOU. Fax (909)594-4205 Pomona, CA. 91768. USA www.remedymakers.com Other information: Contain approx.148 - 153 pellets. CALENDULAOFFICINALIS30C" ], "spl_product_data_elements": [ "CALENDULA OFFICINALIS MARIGOLD CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions : (adult/children) Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 the adult dose." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "INDICATIONS: To be use according to standard homeopathic indications, for self-limiting conditions such as these indicated above or as directed by a physician." ], "set_id": "076ec3e7-e0fd-4531-ba87-be4045200d8c", "id": "8c749e74-2242-43b3-9f1f-5915d9887718" }, { "effective_time": "20110301", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "purpose": [ "OTC - PURPOSE SECTION Formulated for symptoms associated with libido imbalance such as decreased desire, dryness, impotence, anxiety and hypersexuality." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ Chaste Tree Chaste Tree American Ginseng American Ginseng Barium Carbonate Barium Cation Berberis Vulgaris Root Bark Berberis Vulgaris Root Bark Bryonia Alba Root Bryonia Alba Root Dieffenbachia Seguine Dieffenbachia Seguine Lytta Vesicatoria Lytta Vesicatoria Causticum Causticum Chelidonium Majus Chelidonium Majus Cinchona Officinalis Bark Cinchona Officinalis Bark Conium Maculatum Flowering Top Conium Maculatum Flowering Top Gaultheria Procumbens Top Gaultheria Procumbens Top Graphite Graphite Potassium Carbonate Carbonate Ion Lycopodium Clavatum Spore Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Onosmodium Virginianum Whole Onosmodium Virginianum Whole Phosphorus Phosphorus Saw Palmetto Saw Palmetto Selenium Selenium Sepia Officinalis Juice Sepia Officinalis Juice Silicon Dioxide Silicon Dioxide Delphinium Staphisagria Seed Delphinium Staphisagria Seed Goldenseal Goldenseal Thuja Occidentalis Leafy Twig Thuja Occidentalis Leafy Twig Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose." ], "pregnancy_or_breast_feeding": [ "OTC - PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Libido Formulated for symptoms associated with libido imbalance such as decreased desire, dryness, impotence, anxiety and hypersexuality." ], "set_id": "0784b4ec-9874-5b67-adf5-a428b34b1b99", "id": "56ccf59f-6d2b-e071-a9ad-5d4e1bc88eb8", "active_ingredient": [ "OTC - ACTIVE INGREDIENT SECTION Agnus 15x, Aralia quinquefolia 15x, Baryta carb. 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Causticum 15x, Chelidonium majus 15x, Cinchona 15x, Conium 15x, Gaultheria procumbens 15x, Graphites 15x, Kali carb. 15x, Lycopodium 15x, Nux vom. 15x, Onosmodium virginianum 15x, Phosphorus 15x, Sabal 15x, Selenium 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Hydrastis 3x, Thuja occ. 3x." ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves gripping pain in abdomen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Racktim 40 (Number 58) Nux Vomica, Podophyllum Peltatum PODOPHYLLUM PODOPHYLLUM SUCROSE STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Racktim 40 Number 58 Homeopathic Product Nux vomica 200C HPUS, Podophyllum peltatum 30C HPUS Relieves gripping pain in abdomen Quantity 96 Pills Racktim 40" ], "indications_and_usage": [ "Uses Relieves gripping pain in abdomen" ], "set_id": "07879288-8e32-35a7-e054-00144ff8d46c", "id": "10162a50-f014-4426-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Nux vomica 200C HPUS, Podophyllum peltatum 30C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve anorexia" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Ruman 40 (Number 34) Lycopodium clavatum, Nux Vomica LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Ruman 40 Number 34 Homeopathic Product Lycopodium clavatum 200C HPUS, Nux vomica 200C HPUS Helps improve anorexia Quantity 96 Pills Ruman 40" ], "indications_and_usage": [ "Uses Helps improve anorexia" ], "set_id": "0795a24d-4fbc-2039-e054-00144ff88e88", "id": "1015dece-f0c3-1e13-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Lycopodium clavatum 200C HPUS, Nux vomica 200C HPUS" ] }, { "effective_time": "20150303", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves cough and chest congestion" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Rattle 40 (Number 506) Bryonia Alba, Ipecacuanha SUCROSE IPECAC IPECAC LACTOSE BRYONIA ALBA ROOT BRYONIA ALBA ROOT" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Rattle 40 Number 506 Homeopathic Product Bryonia alba 200C HPUS, Ipecacuanha 200C HPUS Relieves cough and chest congestion Quantity 96 Pills Rattle 40" ], "indications_and_usage": [ "Uses Relieves cough and chest congestion" ], "set_id": "0798e401-824c-2fce-e054-00144ff8d46c", "id": "10679e92-6f86-526c-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Bryonia alba 200C HPUS, Ipecacuanha 200C HPUS" ] }, { "effective_time": "20110506", "inactive_ingredient": [ "INACTIVE INGREDIENT Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children." ], "purpose": [ "OTC - PURPOSE SPF 8 provides sun protection." ], "warnings": [ "WARNINGS Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children." ], "when_using": [ "OTC - WHEN USING Keep out of eyes." ], "spl_product_data_elements": [ "Flawless Finish Bare Perfection Makeup SPF 8 Honey Beige Octinoxate OCTINOXATE OCTINOXATE WATER TITANIUM DIOXIDE BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE DIMETHICONE OLEIC ACID GLYCERIN POLYSORBATE 40 MAGNESIUM ALUMINUM SILICATE TROLAMINE PHENYL TRIMETHICONE KAOLIN XANTHAN GUM PHENOXYETHANOL SUCROSE LAURATE DICAPRYLYL CARBONATE GLYCERYL MONOSTEARATE METHYLPARABEN DOCOSANOL PROPYLPARABEN SORBITAN MONOPALMITATE Honey Beige" ], "description": [ "DESCRIPTION For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Smooth on to face." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Flawless Finish Bare Perfection Makeup Carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE To Use: Smooth on to face before sun exposure." ], "set_id": "079abd47-697d-45ce-910c-9a1658742d69", "id": "271a0451-07d4-4e0d-8a24-439dda4eb863", "active_ingredient": [ "OTC - ACTIVE INGREDIENT Active Ingredient: Octinoxate 4.0% w/w." ] }, { "effective_time": "20151006", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Varicose Veins, Vomiting" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "CARDUUS MARIANUS CARDUUS MARIANUS MILK THISTLE MILK THISTLE SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "07a4c2a8-6896-4b7c-9dda-d9294d85d23b", "id": "7f9107d5-fef1-4528-ab48-a2d9f7bba67b", "active_ingredient": [ "ACTIVE INGREDIENT CARDUUS MARIANUS HPUS 1X and higher" ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves acidity with water brash" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Stoul 40 (Number 89) Iris Versicolor, Arsenicum Album IRIS VERSICOLOR ROOT IRIS VERSICOLOR ROOT ARSENIC TRIOXIDE ARSENIC CATION (3+) SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Stoul 40 Number 89 Homeopathic Product Iris versicolor 30C HPUS, Arsenicum album 3C HPUS Relieves acidity with water brash Quantity 96 Pills Stoul 40" ], "indications_and_usage": [ "Uses Relieves acidity with water brash" ], "set_id": "07bfe1bf-8de5-5b33-e054-00144ff8d46c", "id": "10da481d-cee1-5afe-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Iris versicolor 30C HPUS, Arsenicum album 3C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals skin eruptions and ring worm infections" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Softcarb 40 (Number 105) Antimonium Crudum, Arsenicum Album ARSENIC TRIOXIDE ARSENIC CATION (3+) ANTIMONY TRISULFIDE ANTIMONY TRISULFIDE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Softcarb 40 Number 105 Homeopathic Product Antimonium crudum 30C HPUS, Arsenicum album 30C HPUS Heals skin eruptions and ring worm infections Quantity 96 Pills Softcarb 40" ], "indications_and_usage": [ "Uses Heals skin eruptions and ring worm infections" ], "set_id": "07c0fb5c-187c-70da-e054-00144ff8d46c", "id": "101685ab-f26f-1fa8-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Antimonium crudum 30C HPUS, Arsenicum album 30C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Treats lethargy, lack of energy, sleepiness during the day" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Sloth 40 (Number 104) Argentum Metallicum, Rhus Toxicodendron SILVER NITRATE SILVER CATION TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Sloth 40 Number 104 Homeopathic Product Argentum nitricum 200C HPUS, Rhus toxicodendron 200C HPUS Treats lethargy, lack of energy, sleepiness during the day Quantity 96 Pills Sloth 40" ], "indications_and_usage": [ "Uses Treats lethargy, lack of energy, sleepiness during the day" ], "set_id": "07c20fac-0e39-39e8-e054-00144ff8d46c", "id": "101685ab-f27a-1fa8-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Argentum nitricum 200C HPUS, Rhus toxicodendron 200C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve phimosis" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Sidni 40 (Number 64) Mercurius Solubilis, Silicea MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS SILICON DIOXIDE SILICON DIOXIDE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Sidni 40 Number 64 Homeopathic Product Mercurius solubilis 30C HPUS, Silicea 30C HPUS Helps improve phimosis Quantity 96 Pills Sidni 40" ], "indications_and_usage": [ "Uses Helps improve phimosis" ], "set_id": "07c2cc3e-3d8b-0547-e054-00144ff88e88", "id": "10174af9-1dde-6781-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Mercurius solubilis 30C HPUS, Silicea 30C HPUS" ] }, { "effective_time": "20150228", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Soothes sore throat" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Spaskas 40 (Number 45) Calcarea Sulphurica, Atropa Belladonna ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE LACTOSE CALCIUM SULFATE ANHYDROUS CALCIUM CATION" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Spaskas 40 Number 45 Homeopathic Product Calcarea sulphurica 6C HPUS, Belladonna 30C HPUS Soothes sore throat Quantity 96 Pills Spaskas 40" ], "indications_and_usage": [ "Uses Soothes sore throat" ], "set_id": "07c336e9-9e8c-68a0-e054-00144ff8d46c", "id": "101e6d53-3df7-0d79-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Calcarea sulphurica 6C HPUS, Belladonna 30C HPUS" ] }, { "effective_time": "20150227", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves pain in throat" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Sadaton 40 (Number 123) Bryonia Alba, Belladonna BRYONIA ALBA ROOT BRYONIA ALBA ROOT ATROPA BELLADONNA ATROPA BELLADONNA SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Sadaton 40 Number 123 Homeopathic Product Bryonia alba 30C HPUS, Belladonna 200C HPUS Relieves pain in throat Quantity 96 Pills Sadaton 40" ], "indications_and_usage": [ "Uses Relieves pain in throat" ], "set_id": "07c40915-2f3e-3093-e054-00144ff88e88", "id": "101758cf-9fb7-44b8-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Bryonia alba 30C HPUS, Belladonna 200C HPUS" ] }, { "effective_time": "20150225", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Helps improve fast pulse or tachycardia" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Indigit 40 (Number 568) Arnica montana, Aconitum napellus ARNICA MONTANA ARNICA MONTANA ACONITUM NAPELLUS ACONITUM NAPELLUS SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Indigit 40 Number 568 Homeopathic Product Arnica montana 30C HPUS, Aconitum napellus 30C HPUS Helps improve fast pulse or tachycardia Quantity 96 Pills Indigit 40" ], "indications_and_usage": [ "Uses Helps improve fast pulse or tachycardia" ], "set_id": "08365334-ee82-2c42-e054-00144ff88e88", "id": "0feec3fb-a668-529b-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Arnica montana 30C HPUS, Aconitum napellus 30C HPUS" ] }, { "effective_time": "20150302", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Relieves obstinate joint pain" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Blith 40 (Number 536) Lithium carbonicum, Rhus toxicodendron SUCROSE LACTOSE LITHIUM CARBONATE LITHIUM CATION TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Blith 40 Number 536 Homeopathic Product Lithium carbonicum 6C HPUS, Rhus toxicodendron 200C HPUS Relieves obstinate joint pain Quantity 96 Pills Blith 40" ], "indications_and_usage": [ "Uses Relieves obstinate joint pain" ], "set_id": "085cdf30-fd36-62e5-e054-00144ff88e88", "id": "1053fa6d-b522-3017-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Lithium carbonicum 6C HPUS, Rhus toxicodendron 200C HPUS" ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Gastritis - Ulcer Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Cinchona, Colocynthis, Graphites, Hepar sulph. calc., Hydrastis, Ipecac., Kali bic., Kali carb., Lycopodium, Mag. carb. Mag. phos., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta,Taraxacum Antimony Trisulfide Antimony Trisulfide Silver Nitrate Silver Cation Arsenic Trioxide Arsenic Cation (3+) Baptisia Tinctoria Baptisia Tinctoria Bismuth Bismuth Bryonia Alba Root Bryonia Alba Root Cinchona Officinalis Bark Cinchona Officinalis Bark Citrullus Colocynthis Fruit Pulp Citrullus Colocynthis Fruit Pulp Graphite Graphite Calcium Sulfide Calcium Sulfide Goldenseal Goldenseal Ipecac Ipecac Potassium Dichromate Dichromate Ion Potassium Carbonate Carbonate Ion Lycopodium Clavatum Spore Lycopodium Clavatum Spore Magnesium Carbonate Carbonate Ion Magnesium Phosphate, Dibasic Trihydrate Magnesium Cation Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Phosphorus Phosphorus Podophyllum Podophyllum Pulsatilla Vulgaris Pulsatilla Vulgaris Ginger Ginger Matricaria Recutita Matricaria Recutita Echinacea, Unspecified Echinacea, Unspecified Iris Versicolor Root Iris Versicolor Root Ruta Graveolens Flowering Top Ruta Graveolens Flowering Top Taraxacum Officinale Taraxacum Officinale Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 pellets orally one to four times daily or as directed by a healthcare professional." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Gastritis - Ulcer Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers." ], "set_id": "0863075b-3e85-a539-ae7a-1631e1f6efd9", "id": "07b513e4-38e3-49c8-d444-85752ad9d613", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Antimon. crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona 15x, Colocynthis 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Ipecac. 15x, Kali bic. 15x, Kali carb.15x, Lycopodium 15x, Mag. carb. 15x, Mag. phos. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Zingiber 15x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x." ] }, { "effective_time": "20141122", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals cuts & bruises, useful for all kinds of injuries, pains and sprain relief" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose get medical help or contact a poison control center." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Arnica montana 3C Arnica montana ARNICA MONTANA ARNICA MONTANA SUCROSE LACTOSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by P. Banerji Mihijam Pharmaceuticals 5/1D Deshapriya Park East, Kolkata - 700 029 (Product of INDIA) +91-33-6607-7000" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Arnica montana 3C Homeopathic Product Arnica montana 3C Heals cuts & bruises, useful for all kinds of injuries, pains and sprain relief Quantity 96 Pills Arnica montana 3C" ], "indications_and_usage": [ "Uses Heals cuts & bruises, useful for all kinds of injuries, pains and sprain relief" ], "set_id": "08718ab0-7659-63c4-e054-00144ff8d46c", "id": "08718ab0-765a-63c4-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Arnica montana 3C" ] }, { "effective_time": "20110601", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets." ], "abuse": [ "PURPOSE SECTION Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness ." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children." ], "warnings": [ "WARNINGS SECTION Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children." ], "questions": [ "QUESTIONS? SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256" ], "spl_product_data_elements": [ "Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum Picea Mariana Resin Picea Mariana Resin Horse Chestnut Horse Chestnut Aloe Aloe Aluminum Oxide Aluminum Oxide Bryonia Alba Root Bryonia Alba Root Activated Charcoal Activated Charcoal Chelidonium Majus Chelidonium Majus Collinsonia Canadensis Root Collinsonia Canadensis Root Graphite Graphite Goldenseal Goldenseal Potassium Carbonate Carbonate Ion Lycopodium Clavatum Spore Lycopodium Clavatum Spore Magnesium Chloride Magnesium Cation Daphne Mezereum Bark Daphne Mezereum Bark Strychnos Nux-vomica Seed Strychnos Nux-vomica Seed Podophyllum Podophyllum Frangula Purshiana Bark Frangula Purshiana Bark Sanicula Europaea Whole Sanicula Europaea Whole Selenium Selenium Sepia Officinalis Juice Sepia Officinalis Juice Silicon Dioxide Silicon Dioxide Tobacco Leaf Tobacco Leaf Veratrum Album Root Veratrum Album Root Zinc Zinc Echinacea, Unspecified Echinacea, Unspecified Iris Versicolor Root Iris Versicolor Root Phytolacca Americana Root Phytolacca Americana Root Taraxacum Officinale Taraxacum Officinale Sucrose package label" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days." ], "package_label_principal_display_panel": [ "PACKAGE LABEL" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION Constipation Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness ." ], "set_id": "08c02b39-eef6-14fa-6547-57add86db727", "id": "e884e313-298e-fbca-b877-71a3e227b886", "active_ingredient": [ "ACTIVE INGREDIENT SECTION Abies nig. 20x, Aesculus hipp. 20x, Aloe 20x, Alumina 20x, Bryonia 20x, Carbo veg. 20x, Chelidonium majus 20x, Collinsonia 20x, Graphites 20x, Hydrastis 20x, Kali carb. 20x, Lycopodium 20x, Mag. mur. 20x, Mezereum 20x, Nux vom. 20x, Podoph. pelt. 20x, Rhamnus purshiana 20x, Sanicula 20x, Selenium 20x, Sepia 20x, Silicea 20x, Tabacum 20x, Veratrum alb. 20x, Zinc.met. 20x, Echinacea 8x, Iris versicolor 8x, Phytolacca 8x, Taraxacum 8x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x." ] }, { "effective_time": "20111115", "inactive_ingredient": [ "Inactive ingredients Acesulfame potassium, asorbic acid, corn syrup, FD&C red #40, dried pomegranate, green tea extract, natural and artificial blackberry, blueberry, raspberry and strawberry flavors, propylene glycol, sodium ascorbate, sucrose." ], "purpose": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore throat warning Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, nausea or vomiting may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "QUESTIONS CALL 1-800-344-7239" ], "spl_product_data_elements": [ "Sucrets Herbal Berry Pomegranate Menthol and Pectin MENTHOL MENTHOL PECTIN PECTIN ACESULFAME POTASSIUM ASCORBIC ACID CORN SYRUP FD&C RED NO. 40 POMEGRANATE BLACKBERRY BLUEBERRY PROPYLENE GLYCOL SODIUM ASCORBATE SUCROSE" ], "ask_doctor": [ "Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 3 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 1 hour as needed or as directed by a doctor or dentist. children under 3 years of age: consult a doctor or dentist." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY: INSIGHT PHARMACEUTICALS CORP. LANGHORNE, PA 19047-1749" ], "stop_use": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other Information Avoid storing at high temperature (greater than 100°F). Use only if lozenge blister seals are unbroken" ], "active_ingredient_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL- 18 Lozenges Container SUCRETS ® HERBAL PECTIN / DEMULCENT • MENTHOL / COUGH SUPPRESSANT Serious Relief of Sore Throat Protects Irritated Throat Suppresses Cough PLUS Vitamin C 18 LOZENGES Made with Green Tea Berry Pomegranate 66006B Principal Display Panel - 18 Lozenges Container" ], "indications_and_usage": [ "Uses temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth cough associated with a cold or inhaled irritants for protection of irritated areas in sore mouth and throat" ], "set_id": "08f56f2a-86c0-447b-9abb-e139cc6208e9", "id": "2cbbec9a-39e1-4440-b3e0-baead1077006", "purpose_table": [ "
Active ingredient (per lozenge) Purpose
Menthol 5.0 mg Cough Suppressant
Pectin 6.0 mg Demulcent
" ], "active_ingredient": [ "Active ingredient (per lozenge) Purpose Menthol 5.0 mg Cough Suppressant Pectin 6.0 mg Demulcent" ] }, { "effective_time": "20151228", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose/Lactose" ], "purpose": [ "USES To relieve the symptoms of nasal discharge, sneezing, loss of smell, burning eyes with tearing, frequent hawking up of mucus." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of reach of children." ], "warnings": [ "STOP USE AND ASK DOCTOR If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner." ], "spl_product_data_elements": [ "Head Cold POTASSIUM MERCURIC IODIDE - GELSEMIUM SEMPERVIRENS ROOT - EUPHRASIA STRICTA POTASSIUM MERCURIC IODIDE MERCURIC CATION SUCROSE LACTOSE GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT EUPHRASIA STRICTA EUPHRASIA STRICTA white" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS Adults 2 pellets every 3 hours for 2 days. Then 2 pellets morning and night for 2 weeks. Children: 1 pellet. Repeat as necessary." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Enter section text here image of bottle label" ], "indications_and_usage": [ "INDICATIONS Indications: MERC CUM KALI Swollen glands GELSEMIUM Lethargy EUPHRASIA Eye irritation" ], "set_id": "091b7dfd-3cfe-4aca-89a1-558afb4d65c6", "id": "d68a0cbf-38ec-43bf-8628-1658aa84a0b5", "active_ingredient": [ "ACTIVE INGREDIENTS MERC CUM KALI 6C GELSEMIUM 6C EUPHRASIA 6C" ] }, { "effective_time": "20111219", "inactive_ingredient": [ "Cyclopentasiloxane, Stearyl Alcohol, Hydrogenated Polydecene, Hydrogenated Castor Oil, Parfum/Fragrance, Silica, Caesalpinia Spinosa Gum, PEG-100 Stearate, Glyceryl Stearate, Sorbitan Sesquioleate, Sucrose Stearate, Dimethicone, Gossypium Herbaceum (Cotton) Powder, Aminopropyl Dimethicone." ], "purpose": [ "Antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only. Do not use on broken skin. Ask a doctor before use if you have kidney disease. Stop use if rash or irritation occurs." ], "spl_product_data_elements": [ "Adidas Action 3 Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY CYCLOMETHICONE 5 STEARYL ALCOHOL HYDROGENATED CASTOR OIL Silicon Dioxide CAESALPINIA SPINOSA RESIN PEG-100 STEARATE GLYCERYL MONOSTEARATE SORBITAN SESQUIOLEATE SUCROSE STEARATE DIMETHICONE GOSSYPIUM HERBACEUM ROOT BARK" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply to underarms as needed." ], "package_label_principal_display_panel": [ "AM FRESH 1_8 F", "AM FRESH 1_8 B" ], "indications_and_usage": [ "Reduces underarm perspiration." ], "set_id": "0930e211-0b8b-4584-85b1-15761fba36e1", "id": "20e1fd1b-64f7-4fa7-8e5c-496d3153ab02", "active_ingredient": [ "Aluminum Zirconium Tetrachlorohydrex GLY 18% w/w" ] }, { "effective_time": "20120912", "inactive_ingredient": [ "INACTIVE INGREDIENTS Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax" ], "purpose": [ "PURPOSES Pain reliever/Fever reducer Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days redness or swelling is present in the painful area If pregnant or breast-feeding Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride IBUPROFEN IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GUAR GUM TRISTEARIN HYDROXYPROPYL CELLULOSE FERROSOFERRIC OXIDE KAOLIN POLYETHYLENE GLYCOLS POWDERED CELLULOSE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX 423 Caplets" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days redness or swelling is present in the painful area" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25 ○ C (68 - 77 ○ F). Avoid excessive heat above 40 ○ C (104 ○ F). read all warnings and directions before use. Keep carton. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL QC QUALITY CHOICE ® NDC 63868-453-20 * Compare to the active ingredients in Advil ® Cold & Sinus NON-DROWSY IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP Cold & Sinus Formula Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID) ٭ Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant FOR RELIEF OF: Sinus Pressure Nasal Congestion Fever 20 COATED CAPLETS † ( † Oval-Shaped Tablets) ٭ nonsteroidal anti-inflammatory drug © DISTRIBUTED BY QUALITY CHOICE 5089124/R0811 This is the 20 count blister carton label for Quality Choice Ibuprofen and Pseudoephedrine HCl Tablets, USP." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms associated with the common cold or flu: fever sinus pressure nasal congestion headache minor body aches and pains" ], "set_id": "093e6388-54f2-4d04-ba55-8f7c9c182a0e", "id": "9b971e5f-98b5-4030-96d0-2b8aa5c03609", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH CAPLET) Ibuprofen, USP 200 mg (NSAID) * Pseudoephedrine HCl, USP 30 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151031", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Chorea" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "SCUTELLARIA LATERIFLORA SCUTELLARIA LATERIFLORA SCUTELLARIA LATERIFLORA SCUTELLARIA LATERIFLORA SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "09584000-07a4-4fba-823f-3608e5f717b9", "id": "e571a141-eb81-4815-aa9b-d3e2c64cce9a", "active_ingredient": [ "ACTIVE INGREDIENT SCUTELLARIA LATERIFLORA HPUS 1X and higher" ] }, { "effective_time": "20110608", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Sucrose, Lactose." ], "purpose": [ "USE: Body care: arthritis, rheumatism, tendon and ligament strains. Also use for poison ivy and skin irritations." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF KID'S REACH." ], "warnings": [ "WARNINGS: If conditions persist, contact your doctor. When pregnant or nursing, seek council. Keep out of kid's reach. Do not use if cap band is missing." ], "questions": [ "HISTORICAL REMEDIES 122 S. Wabasha, Saint Paul, MM 55107 TOLL FREE: 800-676-6654" ], "spl_product_data_elements": [ "Rhus Tox Rhus toxicodendron, TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SUCROSE LACTOSE" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS: Dissolve or swallow 4 pellets adults or 2 pellets children. Take every half hour if needed, or 6-7 times per day." ], "package_label_principal_display_panel": [ "100 Homeopathic Dose Rhus Tox Rhus Toxicodendron HPUS 12X BACK AND JOINT ACHE HISTORICAL REMEDIES Rhus Tox" ], "indications_and_usage": [ "USE: Body care: arthritis, rheumatism, tendon and ligament strains. Also use for poison ivy and skin irritations." ], "set_id": "095926a5-953d-4766-bfe1-a1bec850e55d", "id": "3d0fa488-ec25-4846-85e0-d33a1a0effc3", "active_ingredient": [ "ACTIVE INGREDIENTS: Rhus toxicodendron 12X." ] }, { "effective_time": "20150302", "inactive_ingredient": [ "Inactive Ingredients Sucrose, Lactose" ], "purpose": [ "Purpose Heals dry eruptions on skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings If pregnant or breast feeding ask a health professional before use." ], "spl_product_data_elements": [ "Drich 40 (Number 113) Antimonium crudum, Hepar sulphuris calcareum ANTIMONY TRISULFIDE ANTIMONY TRISULFIDE CALCIUM SULFIDE CALCIUM SULFIDE SUCROSE LACTOSE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician." ], "spl_unclassified_section": [ "Manufactured by Paramesh Banerji Life Sciences, LLC 220 North Center Drive North Brunswick, NJ 08902, USA Product of USA Tel: +1-732-743-5936" ], "package_label_principal_display_panel": [ "Principal Display Panel Homeopathic Product Drich 40 Number 113 Homeopathic Product Antimonium crudum 30C HPUS, Hepar sulphur 200C HPUS Heals dry eruptions on skin Quantity 96 Pills Drich 40" ], "indications_and_usage": [ "Uses Heals dry eruptions on skin" ], "set_id": "09763398-b7ab-0532-e054-00144ff8d46c", "id": "1053fa6d-b527-3017-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Antimonium crudum 30C HPUS, Hepar sulphur 200C HPUS" ] }, { "effective_time": "20151010", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Chills & Sneezing" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "CAMPHORA CAMPHORA CAMPHOR (NATURAL) CAMPHOR (NATURAL) SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "09826ded-6084-4274-b694-6ce21cca9586", "id": "1809ed3a-b684-4c7e-9621-b1867660fb79", "active_ingredient": [ "ACTIVE INGREDIENT CAMPHORA HPUS 1X and higher" ] }, { "effective_time": "20100726", "inactive_ingredient": [ "Sucrose (inactive ingredient)" ], "purpose": [ "Relieves nausea and vomiting in children" ], "keep_out_of_reach_of_children": [ "Keep this and all medicines from the reach of children." ], "pregnancy": [ "If pregnant or breastfeeding, ask a health professional before use." ], "warnings": [ "Contains no gluten, artificial flavors, colors or preservatives. Safe for all ages and during pregnancy." ], "spl_product_data_elements": [ "KiddieVom Zingiber, Cocculus, Chamomilla , Arsenicum alb , Ipecac , Sucrose CARDAMOM CARDAMOM JATEORHIZA CALUMBA ROOT JATEORHIZA CALUMBA ROOT CHAMOMILE CHAMOMILE ARSENIC TRIOXIDE ARSENIC CATION (3+) ASCLEPIAS CURASSAVICA ASCLEPIAS CURASSAVICA SUCROSE white sucrose granules" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Dosage: 1 pinch onto the tongue hourly as needed." ], "general_precautions": [ "Caution: If symptoms persist or worsen, a health care professional should be consulted." ], "information_for_patients": [ "All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com Distributed by Native Remedies, LLC 6531 Park of Commerce Blvd. Suite 160 Boca Raton, FL 33487 Phone: 1.877.289.1235 International: + 1.561.999.8857 The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States." ], "package_label_principal_display_panel": [ "bottle label" ], "indications_and_usage": [ "Indications: Homeopathic remedy for nausea and vomiting in children." ], "set_id": "09cda11b-ce95-4873-8ebb-41a738230b9a", "id": "3231db0b-cd48-43e0-b8bf-058d788b6c7e", "active_ingredient": [ "Ingredients: Each dose contains equal parts of Zingiber (3X) (HPUS), Cocculus (3C) (HPUS), Chamomilla (30C) (HPUS), Arsenicum alb (6C) (HPUS), Ipecac (6C) (HPUS)" ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients corn syrup, D&C yellow no. 10, FD&C blue no. 1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water" ], "purpose": [ "Purpose Oral anesthetic Oral anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 12 years of age. Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . In case of an accidental overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-634-7680" ], "spl_product_data_elements": [ "Medique Sepasoothe HEXYLRESORCINOL, MENTHOL HEXYLRESORCINOL HEXYLRESORCINOL MENTHOL MENTHOL CORN SYRUP D&C YELLOW NO. 10 FD&C BLUE NO. 1 METHYL SALICYLATE PROPYLENE GLYCOL SUCROSE TITANIUM DIOXIDE WATER green OVAL N" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed Adults and children : (12 years and older) Allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all warnings and directions before use. TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering. store at room temperature 15º-30ºC (59º-86ºF) protect from moisture" ], "stop_use": [ "Stop using this product and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days" ], "package_label_principal_display_panel": [ "909B Medique Sepasoothe Label Medique ® Sepasoothe Pull to Open Hexylresorcinol 2.4 mg Menthol 4.5 mg Anesthetic 24 Lozenges (24 x 1) 909B Medique Sepasoothe Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms occasional minor irritation pain sore mouth sore throat" ], "set_id": "0a122ebb-1f33-40ff-857e-861bee77ff57", "id": "5e47d38b-2b5f-44e9-a55a-2d9d27e1fe05", "active_ingredient": [ "Active ingredient (in each lozenge) Hexylresorcinol 2.4mg Menthol 4.5mg" ] }, { "effective_time": "20151010", "inactive_ingredient": [ "INACTIVE INGREDIENTS Sucrose" ], "purpose": [ "USES Colitis, Hip Pains" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children" ], "warnings": [ "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use." ], "questions": [ "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758" ], "spl_product_data_elements": [ "ALLIUM SATIVUM ALLIUM SATIVUM GARLIC GARLIC SUCROSE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose." ], "pregnancy_or_breast_feeding": [ "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product" ], "stop_use": [ "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional" ], "storage_and_handling": [ "STORAGE Store in a cool dark place" ], "do_not_use": [ "Do not use if capseal is broken or missing. Close the cap tightly after use." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "INDICATIONS Condition listed above or as directed by the physician" ], "set_id": "0a152d3d-6087-4390-891e-f67f8b341675", "id": "429e49f8-698c-4392-91c6-175261161e1a", "active_ingredient": [ "ACTIVE INGREDIENT ALLIUM SATIVUM HPUS 1X and higher" ] }, { "effective_time": "20120531", "inactive_ingredient": [ "Inactive Ingredients Sucrose Lactose Microcrystalline cellulose Clear coating Stearic Acid Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Sucralose" ], "purpose": [ "Homeopathic Purpose Kali Sulphuricum 6x Chirping, Crackling, Humming Salicylicum Acidum 6x,12x Roaring, Ringing, Buzzing Silicea 6x Pain, Discomfort Calcarea Sulphuricum 6x Inner Ear Problems Chininum Sulphuricum 12x Hardness of Hearing Thiosinaminum 6x,12x Eardrum Problems" ], "keep_out_of_reach_of_children": [ "Keep this and all medicines out of reach of children." ], "warnings": [ "Warnings - Consult with your doctor prior to use if you are currently taking blood thinning medications or if you are a pregnant or nursing. - Initial worsening of symptoms may occur. - If symptoms persist or worsen, consult your doctor." ], "questions": [ "TRP Company 1575 Delucchi Lane #115 Reno, NV 89502 888-969-6855 www.trpcompany.com" ], "spl_product_data_elements": [ "Ring Relief Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea Potassium Sulfate Potassium Cation Salicylic Acid Salicylic Acid Silicon Dioxide Silicon Dioxide Calcium Sulfate Anhydrous Calcium Cation Quinine Sulfate Quinine Allylthiourea Allylthiourea Citrus Bioflavonoids Citrus Bioflavonoids Ginkgo Ginkgo Thiamine Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pantothenic Acid Pantothenic Acid Pyridoxine Pyridoxine Cyanocobalamin Cyanocobalamin Biotin Biotin Folic Acid Folic Acid Inositol Inositol Zinc Picolinate Zinc Picolinate Ascorbic Acid Ascorbic Acid Sucrose Lactose Cellulose, Microcrystalline Stearic Acid Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Sucralose Tablet None" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Take 1 caplet, morning and evening, 5 minutes before or 20 minutes after a meal. Let the homeopathic external shell dissolve in your mouth until the sweetness is gone (approx. 20-40 seconds), then swallow the remaining vitamin enriched core with water. For faster results take 1 caplet 3 times per day. For best results, use for at least 6 months. After desired results are achieved, reduce dosing to 1 caplet 2 times per day." ], "stop_use": [ "Stop Use and See A Doctor If You experience ear pain or prolonged worsening of symptoms." ], "spl_unclassified_section": [ "Other Information Tinnitus may be a symptom of a more serious health condition and your doctor should be consulted for proper diagnosis. Over the counter drugs like aspirin or drugs such as caffeine and tobacco can aggravate tinnitus. For maximum results, and especially if earwax build up is an issue, use caplets with Ring Relief Ear Drops." ], "do_not_use": [ "Do not use If tamper evident seal is broken." ], "active_ingredient_table": [ "
Kali Sulphuricum 6x
Salicylicum Acidum 6x,12x
Silicea 6x
Calcarea Sulphuricum 6x
Chininum Sulphuricum 12x
Thiosinaminum 6x,12x
Citrus Bioflavonoids 300 mg
Ginkgo 30 mg
Thiamine 0.5 mg
Riboflavin 0.5 mg
Niacinamide 10 mg
Pantothenic Acid 2.5 mg
Pyridoxine 0.5 mg
Cyanocobalamin 200 mcg
Biotin 100 mcg
Folic Acid 200 mcg
Inositol 37.5 mg
Zinc Picolinate 7.5 mg
Ascorbic Acid 150 mg
" ], "package_label_principal_display_panel": [ "Bottle image Box image" ], "indications_and_usage": [ "Uses According to homeopathic indications these ingredients provide temporary relief from symptoms of Tinnitus such as: - Ringing - Buzzing - Noises in ears - Pain and Discomfort" ], "set_id": "0a38f93c-cf61-48f0-be17-909c7a6485c6", "id": "747751c1-49c6-499c-9f28-93806138de11", "purpose_table": [ "
Kali Sulphuricum 6x Chirping, Crackling, Humming
Salicylicum Acidum 6x,12x Roaring, Ringing, Buzzing
Silicea 6x Pain, Discomfort
Calcarea Sulphuricum 6x Inner Ear Problems
Chininum Sulphuricum 12x Hardness of Hearing
Thiosinaminum 6x,12x Eardrum Problems
" ], "inactive_ingredient_table": [ "
Sucrose
Lactose
Microcrystalline cellulose
Clear coating
Stearic Acid
Croscarmellose Sodium
Silicon Dioxide
Magnesium Stearate
Sucralose
" ], "active_ingredient": [ "Active Ingredients Kali Sulphuricum 6x Salicylicum Acidum 6x,12x Silicea 6x Calcarea Sulphuricum 6x Chininum Sulphuricum 12x Thiosinaminum 6x,12x Citrus Bioflavonoids 300 mg Ginkgo 30 mg Thiamine 0.5 mg Riboflavin 0.5 mg Niacinamide 10 mg Pantothenic Acid 2.5 mg Pyridoxine 0.5 mg Cyanocobalamin 200 mcg Biotin 100 mcg Folic Acid 200 mcg Inositol 37.5 mg Zinc Picolinate 7.5 mg Ascorbic Acid 150 mg" ] } ] }