{ "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": "2026-08-07", "results": { "skip": 0, "limit": 100, "total": 15 } }, "results": [ { "effective_time": "20111104", "inactive_ingredient": [ "Inactive ingredients acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake" ], "purpose": [ "for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "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 stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. 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 chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk" ], "spl_product_data_elements": [ "Dulcolax bisacodyl bisacodyl bisacodyl acacia carnauba wax cellacefate starch, corn dibutyl phthalate docusate sodium gelatin glycerin kaolin lactose magnesium stearate methylparaben shellac polyethylene glycol povidone propylparaben sodium benzoate sorbitan monooleate sucrose talc titanium dioxide white wax 12;" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years of age and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 2 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 no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "storage_and_handling": [ "Other information store at 20-25°C (68-77°F protect from excessive humidity" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "active_ingredient_table": [ "
Active ingredient (in each tablet) Purpose
Bisacodyl USP 5 mg .................................... Stimulant laxative
" ], "package_label_principal_display_panel": [ "Dulcolax (bisacodyl USP) laxative tablets 5 mg NDC 54868-0016-0 image of package label" ], "indications_and_usage": [ "Uses for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "2913bcab-0cef-4796-9726-5906f4ec63f8", "id": "6dee501e-2e58-4ff2-901b-8f8693c776b7", "active_ingredient": [ "Drug Facts Active ingredient (in each tablet) Purpose Bisacodyl USP 5 mg .................................... Stimulant laxative" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 2 years of age ask a doctor
" ] }, { "effective_time": "20100929", "inactive_ingredient": [ "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE", "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE", "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE" ], "contraindications": [ "CONTRAINDICATIONS This drug should not be used by those sensitive to Arnica or any of the other listed ingredients." ], "spl_product_data_elements": [ "TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA ECHINACEA PURPUREA ECHINACEA PURPUREA ACONITUM NAPELLUS ACONITUM NAPELLUS ARNICA MONTANA ARNICA MONTANA CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ATROPA BELLADONNA ATROPA BELLADONNA BELLIS PERENNIS BELLIS PERENNIS CHAMOMILE CHAMOMILE ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM HYPERICUM OIL HYPERICUM OIL COMFREY ROOT COMFREY ROOT COLCHICINE COLCHICINE WATER ISOPROPYL MYRISTATE LECITHIN, SOYBEAN UREA DOCUSATE SODIUM SODIUM HYDROXIDE" ], "description": [ "DESCRIPTION A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations." ], "warnings_and_cautions": [ "WARNINGS AND PRECAUTIONS For external use only. direct patient not to ingest TRANZEL and to avoid contact with they eyes, mucous membranes, wounds, and damaged skin. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try TRANZGEL again on a test area and monitor the site for additional results. If no rash or redness results, then patient can resume use. However, if the rash persists or redevelops, use should be discontinued. Direct the patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed. In the homeopathic concentrations used to make TRANZGEL, there are no known or expected interactions with other drugs or laboratory tests. In addition, the homeopathic concentrations used are below any levels with known or suspected toxicities." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area." ], "adverse_reactions": [ "ADVERSE REACTIONS Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days." ], "spl_unclassified_section": [ "MANUFACTURED BY FORMULATED SOLUTIONS, LLC CLEARWATER FL 33760 US PATENT #5,654,337 MANUFACTURED BY GENSCO LABORATORIES, LLC INVERNESS, FL 34452 352.726.6284 866.608.6284 WWW.TRANZGEL.COM", "For complete prescribing information, see package insert. Store at room temperature.", "Physical Information PHYSICAL INFORMATION A clear amber colored, viscous gel with a slight floral smell." ], "how_supplied": [ "NDC:50436-9071-1 in a BOTTLE of 50 GELS" ], "information_for_patients": [ "STORE AT ROOM TEMPERATURE Manufactured by Formulated Solutions, LLC Clearwater, FL 33760 Manufactured for Gensco Laboratories, LLC Inverness, FL 34452 352-726-6284 866-608-6284 www.tranzgel.com" ], "package_label_principal_display_panel": [ "TRANZGEL (ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM) GEL Label Image" ], "indications_and_usage": [ "INDICATIONS AND USAGE The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes." ], "clinical_pharmacology": [ "Calendula Officianalis Calendula Inflammation Hamamelis Virginiana Witch-hazel Analgesic Millefolium Yarrow Hematomas Belladonna Banewort Inflammation locally Aconitum Napellus Monk's hood Neuralgia, rheumatism hemostasis, analgeisa Chamomilla Chamomile Inflammation, nausea Colchicinum Colchicine Inflammation and gout Symphytum Officinale Comfrey Neuropathy, contusions, tendonitis, arthritis Bellis Perennis Daisy brusing, edema, arthralgia Echinacea Angustifolia Narrow leaf cone flower Inflammation, myalgia Echinacia purpurea purple cone flower Inflammation, myalgia Hypericum perforatum st. john's wort neuropathic pains CLINICAL PHARMACOLOGY According to traditional homeopathic literature and Material Medica, the following ingredients provide the following attributes: INGREDIENTS COMMON NAME INDICATIONS Arnica Montana Mountain arnica Stimulates healing of injured tissues wounds, contusions, hematomas, neuralgia myalgia, analgesia" ], "set_id": "2d001581-f547-42a5-bc34-0738c2854f04", "id": "efb3d059-ae8d-4c83-a780-e1bbd093c09c", "overdosage": [ "OVERDOSAGE According to toxicology studies, a patient would have to orally ingest a minimum of 22 bottles of TRANZGEL to experience any initial toxic effects." ], "active_ingredient": [ "ACTIVE INGREDIENTS: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS", "ACTIVE INGREDIENTS: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS", "ACTIVE INGREDIENTS: 50 PARTS EACH: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, 30 PARTS: ACONITUM NAPELLUS 3X HPUS, 15 PARTS EACH: ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, 10 PARTS: BELLADONNA 3X HPUS, 5 PARTS EACH: BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, 3 PARTS MILLEFOLIUM 1X HPUS, 1 PART EACH: HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, .01 PART COLCHICINUM 3X HPUS" ] }, { "effective_time": "20111111", "inactive_ingredient": [ "Inactive Ingredients cetyl alcohol, citric acid, dimethyl isosorbide, docusate sodium, hydroxypropyl methylcellulose, laureth -12, magnesium aluminum silicate, propylene glycol, purified water, sodium chloride, sodium hydroxide, sodium lauryl sulfate, and sodium lauryl sulfoacetate." ], "purpose": [ "Purpose Acne treatment" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For External Use Only. When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Do not use if you Have very sensitive skin. Are sensitive to benzoyl peroxide. When using this product Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with the eyes, lips, mouth. Avoid contact with hair and dyed fabrics, which may be bleached by this product. Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop and ask a doctor if Irritation becomes severe." ], "questions": [ "Questions? Comments? Call 1-866-934-6025" ], "spl_product_data_elements": [ "Benzoyl Peroxide Cleansing BENZOYL PEROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE CETYL ALCOHOL CITRIC ACID MONOHYDRATE DIMETHYL ISOSORBIDE DOCUSATE SODIUM HYPROMELLOSE 2208 (100 MPA.S) LAURETH-12 MAGNESIUM ALUMINUM SILICATE PROPYLENE GLYCOL WATER SODIUM CHLORIDE SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM LAURYL SULFOACETATE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Shake well before using. Wash the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply product, working into a full lather. Rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity test for a new user Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above." ], "storage_and_handling": [ "Other Information Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)." ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses For the treatment of acne." ], "set_id": "3433f314-22de-4037-88e0-fc33a369d0ec", "id": "95bb5fe0-4ec1-4a9c-8c82-64bc81453f5a", "active_ingredient": [ "Active Ingredients Benzoyl peroxide 4%" ] }, { "effective_time": "20131111", "purpose": [ "Purpose Pain reliever/fever reducer Pain reliever aid" ], "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." ], "when_using": [ "When using this product Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee." ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "storage_and_handling": [ "Other information • each powder contains: potassium 55 mg • store below 25 o C (77 o F)" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: ∘ headache ∘ muscular aches ∘ minor arthritis pain ∘ colds • temporarily reduces fever" ], "set_id": "433f8b64-f91c-49de-a7c9-1efd3ebe2f20", "id": "f4d66764-e114-4733-9ca3-01406b08d387", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking a prescription drug for diabetes, gout, or arthritis" ], "active_ingredient": [ "Active ingredients (in each powder) Aspirin (NSAID*) 845 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive ingredients docusate sodium, fumaric acid, lactose monohydrate, potassium chloride" ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) 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 aspirin or any other pain reliever/fever reducer Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are Taking a prescription drug for diabetes, gout, or arthritis When using this product Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "spl_product_data_elements": [ "STANBACK aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE" ], "ask_doctor": [ "Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. • do not take more than 4 powders in 24 hours unless directed by a doctor. • children under 12 years of age: ask a doctor." ], "adverse_reactions": [ "Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.", "Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing)", "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" ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use If you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0499-50 STANBACK ® SNAP BACK WITH STANBACK ® Headache Powders ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID RELIEVES PAIN FAST FOR TEMPORARY RELIEF OF MINOR ACHES & PAIN DUE TO HEADACHES - BODY ACHES ARTHRITIS - COLDS & FEVER 50 POWDERS TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR \"S\" TEAR-TAPE IS MISSING OR TORN. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline STANBACK AND SNAP BACK WITH STANBACK are registered trademarks of the GlaxoSmithKline group of companies. 30643XD Stanback Label" ] }, { "effective_time": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 mg 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." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "storage_and_handling": [ "Other information each tablet contains: sodium 416 mg Phenylketonurics: Contains Phenylalanine 9 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold or flu with cough: minor aches and pains nasal and sinus congestion headache sore throat cough temporarily reduces fever" ], "set_id": "66f35119-63f8-4655-af6a-201fe4c8394c", "id": "a076da72-adbd-4b9c-b3c3-a6bdd782466d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 if you are allergic to aspirin or 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 Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis When using this product do not exceed recommended dosage Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "spl_product_data_elements": [ "Alka-Seltzer Plus Day Non Drowsy Cold Medicine Citrus Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate Aspirin Aspirin Dextromethorphan hydrobromide Dextromethorphan Phenylephrine bitartrate Phenylephrine ASP;ND" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use if you are allergic to aspirin or 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" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® DAY NON-DROWSY COLD 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54212 1 MADE IN MEXICO PRODUCT CODE 82411357 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg 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." ], "when_using": [ "When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "storage_and_handling": [ "Other information each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains sinus congestion and pressure sore throat headache cough nasal congestion runny nose sneezing temporarily reduces fever" ], "set_id": "836c1bf4-7aec-4541-94ee-921659192cb3", "id": "297274bc-2bce-44ae-ad25-291ab2b9bbe9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 to sedate children. Do not use if you are allergic to aspirin or 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 Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "spl_product_data_elements": [ "Alka-Seltzer Plus Night Cold Medicine Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide Aspirin Aspirin Doxylamine succinate Doxylamine Phenylephrine bitartrate Phenylephrine Dextromethorphan hydrobromide Dextromethorphan A;S;NT" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, or nasal congestion 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use to sedate children.", "Do not use if you are allergic to aspirin or 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" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® NIGHT COLD FORMULA 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54213 8 MADE IN MEXICO PRODUCT CODE 82411594 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20120831", "inactive_ingredient": [ "Inactive ingredients: acesulfame potassium, aspartame, citric acid, docusate sodium, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "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." ], "purpose": [ "Fast Relief of: Nasal Congetion, Runny Nose, Sneezing, Headache, Sinus Pain and Pressure" ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert: Aspirin may cause a server allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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. 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." ], "when_using": [ "When using this product : - do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor. - do not use more than directed - you may get drowsy - avoid alcoholic drinks - excitability may occur, especially in children - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE ASPIRIN ASPIRIN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE BITARTRATE PHENYLEPHRINE ACESULFAME POTASSIUM ASPARTAME CITRIC ACID MONOHYDRATE DOCUSATE SODIUM MANNITOL POVIDONE K30 SODIUM BENZOATE SODIUM BICARBONATE N&A Lemon Lime Flavor FAKP193 CF" ], "ask_doctor": [ "Ask a doctor before use if - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - glaucome - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis - you are taking a diuretic - been placed on a sodium-restricted diet." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions - do not use more than directed (see overdose warning) - adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours - do not take more than 8 tablets in 24 hours - children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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." ], "adverse_reactions": [ "Adverse Event Reporting: Serious side effects associated with the use of this product can be reported to the following address or by calling the following telephone number." ], "stop_use": [ "Sto p use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody stools - have stomach pain that does not get better - an allergic reaction occurs, seek medical help right away. - pain or nasal congestion gets worse or lasts more than 7 days. - fever gets worse or lasts more than 3 days. - new symptoms occur - redness or swelling is present - ringing in the ears or loss of hearing occurs - nervousness, dizziness or sleeplessness occurs." ], "do_not_use": [ "Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - 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." ], "package_label_principal_display_panel": [ "image of carton" ], "indications_and_usage": [ "Uses: temporarily relieves these symptoms of the common cold: - fever - sneezing - nasal congestion - sore throat - headache - minor aches and pains - runny nose - sinus congestion and pressure" ], "set_id": "9b1ec246-aec2-4279-baf5-43e63e3c0be1", "id": "b3d1e541-da02-4735-81be-b4a45f045c7b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are: - presently taking a prescription drug. - taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis." ], "active_ingredient": [ "Active Ingredients (in each effervescent tablet) Purpose Aspirin 325 mg NSAID *.......................................... Pain reliever/fever reducer Chlorpheniramine maleate 2 mg ............................... Antihistamine Phenylephrine Bitartrate 7.8 mg ............................... Nasal decongestant *Nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130820", "inactive_ingredient": [ "Inactive ingredients docusate sodium, fumaric acid, lactose monohydrate, potassium chloride" ], "purpose": [ "Purpose Pain reliever/fever reducer Pain reliever aid" ], "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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing) 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" ], "when_using": [ "When using this product limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee." ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR \"S\" TEAR-TAPE IS MISSING OR TORN. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 BC and BC in oval device are registered trademarks of the GlaxoSmithKline group of companies. www.bcpowder.com" ], "spl_product_data_elements": [ "BC aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE BC Arthritis aspirin and caffeine ASPIRIN ASPIRIN CAFFEINE CAFFEINE DOCUSATE SODIUM FUMARIC ACID LACTOSE MONOHYDRATE POTASSIUM CHLORIDE" ], "ask_doctor": [ "Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions • adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid. • do not take more than 4 powders in 24 hours unless directed by a doctor. • children under 12 years of age: ask a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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 • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: ∘ feel faint ∘ have stomach pain that does not get better ∘ vomit blood ∘ have bloody or black stools • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • any new symptoms appear • ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "storage_and_handling": [ "Other information Arthritis Formula • each powder contains: potassium 65 mg • store below 25 o C (77 o F) Fast Pain Relief • each powder contains: potassium 55 mg • store below 25 o C (77 o F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0501-50 BC ® ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID FAST PAIN RELIEF Arthritis FORMULA FOR TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN 50 POWDERS ©2011 GlaxoSmithKline 30906XB BC powder Arthritis 50 count carton", "Principal Display Panel NDC 0135-0500-50 BC ® ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER CAFFEINE - PAIN RELIEVER AID FAST PAIN RELIEF FOR PAIN DUE TO HEADACHES TEMPORARY RELIEF OF MINOR BODY ACHES & FEVER 50 POWDERS ©2011 GlaxoSmithKline 30728XD BC powder 50 count carton" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: ∘ headache ∘ muscular aches ∘ minor arthritis pain ∘ colds • temporarily reduces fever" ], "set_id": "a6e77f59-fba7-4a6d-863b-56ab86535341", "id": "cf82d4e6-d90e-4992-8794-7fad67a93ba5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis" ], "active_ingredient": [ "Active ingredient (in each powder) Arthritis Formula Aspirin (NSAID*) 1000 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug Fast Pain Relief Aspirin (NSAID*) 845 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100929", "inactive_ingredient": [ "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE", "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE", "INACTIVE INGREDIENTS: PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE" ], "contraindications": [ "CONTRAINDICATIONS This drug should not be used by those sensitive to Arnica or any of the other listed ingredients." ], "spl_product_data_elements": [ "TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA ECHINACEA PURPUREA ECHINACEA PURPUREA ACONITUM NAPELLUS ACONITUM NAPELLUS ARNICA MONTANA ARNICA MONTANA CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ATROPA BELLADONNA ATROPA BELLADONNA BELLIS PERENNIS BELLIS PERENNIS CHAMOMILE CHAMOMILE ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM HYPERICUM OIL HYPERICUM OIL COMFREY ROOT COMFREY ROOT COLCHICINE COLCHICINE WATER ISOPROPYL MYRISTATE LECITHIN, SOYBEAN UREA DOCUSATE SODIUM SODIUM HYDROXIDE" ], "description": [ "DESCRIPTION A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations." ], "warnings_and_cautions": [ "WARNINGS AND PRECAUTIONS For external use only. direct patient not to ingest TRANZEL and to avoid contact with they eyes, mucous membranes, wounds, and damaged skin. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try TRANZGEL again on a test area and monitor the site for additional results. If no rash or redness results, then patient can resume use. However, if the rash persists or redevelops, use should be discontinued. Direct the patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed. In the homeopathic concentrations used to make TRANZGEL, there are no known or expected interactions with other drugs or laboratory tests. In addition, the homeopathic concentrations used are below any levels with known or suspected toxicities." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area." ], "adverse_reactions": [ "ADVERSE REACTIONS Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days." ], "spl_unclassified_section": [ "MANUFACTURED BY FORMULATED SOLUTIONS, LLC CLEARWATER FL 33760 US PATENT #5,654,337 MANUFACTURED BY GENSCO LABORATORIES, LLC INVERNESS, FL 34452 352.726.6284 866.608.6284 WWW.TRANZGEL.COM", "For complete prescribing information, see package insert. Store at room temperature.", "Physical Information PHYSICAL INFORMATION A clear amber colored, viscous gel with a slight floral smell." ], "how_supplied": [ "Package size: 1.7 fl oz (50 ml) airless pump dispensing bottle US PATENT 5,654,337 NDC 35781-0194-5" ], "information_for_patients": [ "STORE AT ROOM TEMPERATURE Manufactured by Formulated Solutions, LLC Clearwater, FL 33760 Manufactured for Gensco Laboratories, LLC Inverness, FL 34452 352-726-6284 866-608-6284 www.tranzgel.com" ], "package_label_principal_display_panel": [ "NDC 35781-0194-5 TRANZGEL HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 1.7 FL OZ (50 ML) GENSCO LABORATORIES, LLC FOR COMPLETE PRESCRIBING INFORMATION, SEE PACKAGE INSERT. STORE AT ROOM TEMPERATURE. MANUFACTURED BY FORMULATED SOLUTIONS CLEARWATER, FL 33760 US PATENT #5,654,337 MANUFACTURED FOR GENSCO LABORATORIES, LLC INVERNESS, FL 34452 352.726.6284 866.608.6284 WWW.TRANZGEL.COM", "TRANZ GEL HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 1.7 FL OZ (50 ML) GENSCO LABORATORIES", "tranzgel_bottle_label", "Tranzgel_carton_label" ], "indications_and_usage": [ "INDICATIONS AND USAGE The drug is indicated for the relief of symptoms, including pain and inflammation associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic, edema, post surgical edema, hematoma, general swelling of joints and soft tissues) to areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY According to traditional homeopathic literature and Material Medica, the following ingredients provide the following attributes: INGREDIENTS COMMON NAME INDICATIONS Arnica Montana Mountain arnica Stimulates healing of injured tissues wounds, contusions, hematomas, neuralgia myalgia, analgesia Calendula Officianalis Calendula Inflammation Hamamelis Virginiana Witch-hazel Analgesic Millefolium Yarrow Hematomas Belladonna Banewort Inflammation locally Aconitum Napellus Monk's hood Neuralgia, rheumatism hemostasis, analgeisa Chamomilla Chamomile Inflammation, nausea Colchicinum Colchicine Inflammation and gout Symphytum Officinale Comfrey Neuropathy, contusions, tendonitis, arthritis Bellis Perennis Daisy brusing, edema, arthralgia Echinacea Angustifolia Narrow leaf cone flower Inflammation, myalgia Echinacia purpurea purple cone flower Inflammation, myalgia Hypericum perforatum st. john's wort neuropathic pains" ], "set_id": "abc4b131-4d35-46a4-9a8e-9bd4c7a0f4b0", "id": "9135b37f-d8f4-44ae-a7b3-677a1c83ee84", "overdosage": [ "OVERDOSAGE According to toxicology studies, a patient would have to orally ingest a minimum of 22 bottles of TRANZGEL to experience any initial toxic effects." ], "active_ingredient": [ "ACTIVE INGREDIENTS: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS", "ACTIVE INGREDIENTS: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS", "ACTIVE INGREDIENTS: 50 PARTS EACH: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, 30 PARTS: ACONITUM NAPELLUS 3X HPUS, 15 PARTS EACH: ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, 10 PARTS: BELLADONNA 3X HPUS, 5 PARTS EACH: BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, 3 PARTS MILLEFOLIUM 1X HPUS, 1 PART EACH: HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, .01 PART COLCHICINUM 3X HPUS" ] }, { "effective_time": "20130320", "inactive_ingredient": [ "INACTIVE INGREDIENTS Purified water, Isopropyl Myristate, lecithin, Urea, Docusate Sodium, Sodium Hydroxide", "Inactive Ingredients Purified water, Isopropyl Myristate, Lecithin, Urea, Docusate Sodium, Sodium Hydroxide" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "purpose": [ "Speed Gel is indicated for the temporary relief of inflammation and pain from injuries such as sprains, strains, repetitive use injuries, traumatic edema, general swelling of joints and soft tissue of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe. Speed gel is also indicated for the temporary relief of minor pains associated with the inflammation characteristics of Rheumatoid arthritis and the temporary relief of pain associated with the degenerative joint disease Osteoarthritis." ], "warnings": [ "FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES", "WARNINGS For external use only. Avoid contact with eyes. Keep out of reach of children. Use only as directed. Not for use by children unless directed by a physician. As with any drug, if you are pregnant or nursing, seek the advice of a health professional before using this product. If prone to allergies or if rash develops immediately discontinue use. if condition worsens or if pain persists for more than 7 days consult a physician. Keep this and all medicine out of reach of children. In case of accidental ingestion, seek medical attention immediately or consult a poison control center." ], "questions": [ "Questions? Toll Free 1-866-608-6284 Mon-Fri 9AM to 5PM (EST)" ], "spl_product_data_elements": [ "SPEEDGEL Echinacea Purpurea, Echinacea Angustifolia, Aconitum Napellus, Arnica Montana, Calendula Officinallis, Hamamellis Virginiana, Belladonna, Bellis Perennis, Chamomilla, Millefolium, Hypericum Perforatum, Symphytum Officinale ECHINACEA PURPUREA ECHINACEA PURPUREA ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA ACONITUM NAPELLUS ACONITUM NAPELLUS ARNICA MONTANA ARNICA MONTANA CALENDULA OFFICINALIS FLOWER CALENDULA OFFICINALIS FLOWER HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ATROPA BELLADONNA ATROPA BELLADONNA BELLIS PERENNIS BELLIS PERENNIS CHAMOMILE CHAMOMILE ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM HYPERICUM PERFORATUM HYPERICUM PERFORATUM COMFREY ROOT COMFREY ROOT WATER ISOPROPYL MYRISTATE UREA DOCUSATE SODIUM SODIUM HYDROXIDE" ], "warnings_and_cautions": [ "Directions and Warnings Apply a small amount to the affected areas up to four times daily Use only as directed. Not for use by children unless directed by a physician. As with any drug, if you are pregnant or nursing, seek the advice of a health professional before using this product. If prone to allergies or if rash develops immediately discontinue use. if condition worsens or if pain persists for more than 7 days consult a physician. Keep this and all medicine out of reach of children. In case of accidental ingestion, seek medical attention immediately or consult a poison control center." ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Apply a small amount ot the affected areas up to four times daily." ], "information_for_patients": [ "Other Information Store at room temperature", "Manufactured for Gensco Laboratories, LLC Inverness, FL 34452 352.726.6284 | 866.608.6284 US Patent # 5,654,337 www.speedgel.com USE 4 TIMES DAILY TO TREAT: SPORTS INJURIES ARTHRITIS SPRAINS AND STRAINS NECK AND BACK PAIN JOINT AND MUSCLE PAIN BRUISING AND SWELLING SHOULDER AND ELBOW INJURIES KNEE PAIN" ], "package_label_principal_display_panel": [ "NDC 35781-0200-05 WWW.SPEEDGEL.COM SPEEDS HEALING REDUCES PAIN SPG SPEED GEL Homeopathic Medicine Net Contents 1.69 oz (50ml)", "SPEEDS HEALING REDUCES PAIN SPG SPEEDGEL DEEP PENETRATING THERAPY FOR PAINFUL AND INFLAMED MUSCLES, JOINTS AND TENDONS US PATENT #5,654,337 REDUCES INFLAMMATION AND BRUISING BLOCKS PAIN SIGNALS INCREASES RANGE OF MOTION PROMOTES HEALING CARRIES POWERFUL ANTI-INFLAMMATORY AND PAIN RELIEF AGENTS THROUGH THE SKIN TO THE SITE OF YOUR INJURY. NDC 35781-0200-05 SPG SPEEDGEL SPEEDS HEALING REDUCES PAIN HOMEOPATHIC MEDICINE NET CONTENTS 1.69 FL OZ (50 ML) SPG SPEEDGEL SPEEDS HEALING REDUCES PAIN WWW.SPEEDGEL.COM", "speedgelpdp", "speedgeldrugfactspanel", "speedgelouterpanel" ], "indications_and_usage": [ "Speed Gel is indicated for the temporary relief of inflammation and pain from: injuries such as sprains, strains, repetitive use injuries, traumatic edema, general swelling of joints and soft tissue of the hand, wrist, elbow shoulder, neck back, knee, ankle, foot and toe." ], "set_id": "c9c51736-f787-409a-ace6-86f3ca5d21d3", "id": "1701eeda-fe6e-437f-94bd-d233a3683967", "active_ingredient": [ "ACTIVE INGREDIENTS Echinacea Purpurea TINC-HPUS, Echinacea Angustifolia TINC-HPUS, Aconitum Napellus 3X-HPUS, Arnica Montana 3X-HPUS, Calendula Officinallis TINC-HPUS, Hamamellis Virginiana TINC-HPUS, Belladonna 3X-HPUS, Bellis Perennis TINC-HPUS, Chamomilla TINC-HPUS, Millefolium TINC-HPUS, Hypericum Perforatum 6X-HPUS, Symphytum Officinale 4X-HPUS", "DRUG FACTS PURPOSE Echinacea Purpurea TINC-HPUS Inflammation Echinacea Angustifolia TINC-HPUS Inflammation Aconitum Napellus 3X-HPUS Neuralgia Arnica Montana 3X-HPUS Healing of Injured Tissue Calendula Officinallis TINC-HPUS Analgesia Hamamellis Virginiana TINC-HPUS Hematomas Belladonna 3X-HPUS Inflammation Bellis Perennis TINC-HPUS Bruising and Edema Chamomilla TINC-HPUS Tissue Healing Millefolium TINC-HPUS Wound healing Hypericum Perforatum 6X-HPUS Neuropathic Pains Symphytum Officinale 4X-HPUS Neuropathy and Periostitus" ] }, { "effective_time": "20140512", "drug_interactions": [ "ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion." ], "inactive_ingredient": [ "Other Ingredients: Annatto, Beeswax, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Titanium Dioxide and other ancillary ingredients as needed to ensure product stability. This product contains fish and/or algal and soy and has less than 1% EPA. Note: This product does not contain Docusate Sodium but rather instead Docusate Calcium." ], "contraindications": [ "CONTRAINDICATIONS: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a healthcare practitioner." ], "precautions": [ "PRECAUTION: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress." ], "warnings": [ "WARNING: Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day." ], "spl_product_data_elements": [ "Prenatal Vitamin No 53 Iron Fum Folic Acid Docusate CA DHA - ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium, ferrous fumarate, omega-3 fatty acids and docusate capsule, gelatin ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, D- .ALPHA.-TOCOPHEROL, D- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID BIOTIN BIOTIN CALCIUM CALCIUM FERROUS FUMARATE FERROUS CATION OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS DOCUSATE DOCUSATE ANNATTO YELLOW WAX CITRIC ACID MONOHYDRATE ETHYL VANILLIN GLYCERIN WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE opaque brown V251 creamy orange" ], "description": [ "DESCRIPTION: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is an orally administered prescription prenatal/postnatal multivitamin/ mineral softgel with fish-based DHA. PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is available as opaque brown, oblong softgels imprinted “V251” and are available in 30-count bottles (NDC 76439-257-30). Each softgel contains: Vitamin C (ascorbic acid) 28 mg Vitamin D 3 (cholecalciferol) 800 IU Vitamin E (d-alpha tocopherol) 30 IU Vitamin B 6 (pyridoxine hydrochloride) 25 mg Folic Acid 1.25 mg Biotin 250 mcg Calcium 160 mg 158 mg calcium from calcium carbonate and 2 mg calcium from docusate calcium. Iron (ferrous fumarate) 29 mg Omega oil blend 660 mg Providing 350 mg DHA (docosahexaenoic acid). From purified fish and/or algal oil. Docusate CALCIUM 55 mg" ], "boxed_warning": [ "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner." ], "adverse_reactions": [ "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "spl_unclassified_section": [ "Softgels R x", "CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day." ], "storage_and_handling": [ "Store at 20 – 25°C (68 – 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light resistant container. Protect from light and moisture. Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL. 33619 Made in Canada Rev. 4/2014" ], "how_supplied": [ "HOW SUPPLIED: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is available as opaque brown, oblong softgels imprinted “V251” and are available in 30-count bottles (NDC 76439-257-30). KEEP OUT OF REACH OF CHILDREN. This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable. Call your medical practitioner about side effects. You may also report side effects to Virtus Pharmaceuticals, LLC at 813-283-1344." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76439 -257- 30 PRENATAL VITAMIN NO. 53/ IRON FUM/FOLIC ACID/ DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Contains Docusate CALCIUM Rx Prenatal Vitamin with omega oil providing DHA Essential vitamin and minerals Gentle stool softener Softgels R x 30 Softgels PRINCIPAL DISPLAY PANEL - 100 tablets" ], "indications_and_usage": [ "INDICATIONS: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels may be useful in improving the nutritional status of women prior to conception." ], "set_id": "d2acf631-fb29-475f-9b35-64f80f667a8b", "id": "41e317e9-9ec5-48c1-8b2f-ed4a29dd40b9", "description_table": [ "
Each softgel contains:
Vitamin C (ascorbic acid) 28 mg
Vitamin D3 (cholecalciferol) 800 IU
Vitamin E (d-alpha tocopherol) 30 IU
Vitamin B6 (pyridoxine hydrochloride) 25 mg
Folic Acid 1.25 mg
Biotin 250 mcg
Calcium 160 mg158 mg calcium from calcium carbonate and 2 mg calcium from docusate calcium.
Iron (ferrous fumarate) 29 mg
Omega oil blend 660 mgProviding 350 mg DHA (docosahexaenoic acid). From purified fish and/or algal oil.
Docusate CALCIUM 55 mg
" ] }, { "effective_time": "20130920", "purpose": [ "Purposes Pain reliever Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product • drowsiness will occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-866-255-5197 (English/Spanish) weekdays TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline GOODY'S is a registered trademark of the GlaxoSmithKline group of companies. TO OPEN CHILD-RESISTANT PACKAGE 1. Shake pack so powder settles on bottom. 2. Pinch and tear at either arrow or use scissors. 3. Tilt head back and pour powder onto tongue." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information • each powder contains: potassium 55 mg • store below 25°C (77°F)" ], "indications_and_usage": [ "Uses • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "set_id": "d96a522a-9344-416d-8f24-cf3d065078de", "id": "84e5bf75-de7a-4d5f-b540-47d85adb63b5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin • sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each powder) Acetaminophen 500 mg Diphenhydramine Citrate 38 mg" ], "inactive_ingredient": [ "Inactive ingredients citric acid, docusate sodium, fumaric acid, glycine, lactose monohydrate, magnesium stearate, potassium chloride, silica gel, sodium benzoate, sodium citrate dihydrate" ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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. • in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin • sedatives or tranquilizers When using this product • drowsiness will occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts more than 10 days • redness or swelling is present • any new symptoms appear 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. Overdose warning: Taking more than the recommended dose 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." ], "spl_product_data_elements": [ "Goodys PM acetaminophen and diphenhydramine citrate ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE DOCUSATE SODIUM FUMARIC ACID GLYCINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM CHLORIDE SILICON DIOXIDE SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE" ], "ask_doctor": [ "Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • do not take more than directed (see overdose warning) • adults and children 12 years of age and over: take 2 powders at bedtime, if needed, or as directed by a doctor. Drink a full glass of water with each dose, or may stir powders into a glass of water or other liquid. • do not give to children under 12 years of age" ], "stop_use": [ "Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts more than 10 days • redness or swelling is present • any new symptoms appear 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. • in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 10158-003-09 Goody's ® PM Acetaminophen • Diphenhydramine Citrate Pain Reliever/Nighttime sleep-aid NEW NO MESS PACK FAST PAIN RELIEF FOR PAIN WITH SLEEPLESSNESS 16 POWDER PACKS 100025XC Goody's PM 16 count carton" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose 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": "20120106", "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." ], "when_using": [ "When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness and cramps" ], "questions": [ "Questions 1-888-285-9159 (English/Spanish) Or visit www.DULCOLAX.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at 20-25°C (68-77°F) protect from excessive humidity" ], "indications_and_usage": [ "Use for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "eac116c1-d109-4c01-8cd4-ba27ddd2ce40", "id": "92448d56-6df2-40f1-9d69-2f42999ae3c0", "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl USP 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake" ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness and cramps Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. 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." ], "spl_product_data_elements": [ "Dulcolax bisacodyl bisacodyl bisacodyl acacia carnauba wax cellacefate starch, corn dibutyl phthalate docusate sodium gelatin glycerin kaolin lactose magnesium stearate methylparaben shellac polyethylene glycols povidone propylparaben sodium benzoate sorbitan monooleate sucrose talc titanium dioxide white wax diacetylated monoglycerides FERRIC OXIDE RED 12;BI" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Repackaged and distributed by Convenience Valet ® Melrose Park, IL 60160" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package CONVENIENCE CV VALET ® DRINKING CUP INCLUDED Dulcolax ® LAXATIVE (bisacodyl USP 5 mg) C6A 3 TABLETS PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package" ] }, { "effective_time": "20130501", "inactive_ingredient": [ "INACTIVE INGREDIENTS Purified water, Isopropyl Myristate, lecithin, Urea, Docusate Sodium, Sodium Hydroxide", "Inactive Ingredients Purified water, Isopropyl Myristate, Lecithin, Urea, Docusate Sodium" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "purpose": [ "INFLAM-X PRO is indicated for the temporary relief of inflammation and pain from injuries such as sprains, strains, repetitive use injuries, traumatic edema, general swelling of joints and soft tissue of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe. INFLAM-X PRO is also indicated for the reduction of bruising." ], "warnings": [ "FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES", "WARNINGS For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued. Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed." ], "questions": [ "Questions? Toll Free 1-866-608-6284 Mon-Fri 9AM to 5PM (EST)" ], "spl_product_data_elements": [ "INFLAM-X Aconitum Napellus, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinallis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamellis Virginiana, Hypericum Perforatum, Millefolium, Symphytum Officinale, Zingiber Officinale ACONITUM NAPELLUS ACONITUM NAPELLUS ARNICA MONTANA ARNICA MONTANA ATROPA BELLADONNA ATROPA BELLADONNA BELLIS PERENNIS BELLIS PERENNIS CALENDULA OFFICINALIS FLOWER CALENDULA OFFICINALIS FLOWER CHAMOMILE CHAMOMILE ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA ECHINACEA PURPUREA ECHINACEA PURPUREA HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HYPERICUM PERFORATUM HYPERICUM PERFORATUM ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM COMFREY ROOT COMFREY ROOT GINGER GINGER WATER ISOPROPYL MYRISTATE UREA DOCUSATE SODIUM SODIUM HYDROXIDE" ], "warnings_and_cautions": [ "For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued. Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area of the skin 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area. Safe to use on children over age of 2 years." ], "information_for_patients": [ "Other Information Store at room temperature", "Manufactured for Gensco Laboratories, LLC Miramar, FL 33027 866.608.6284 US Patent # 5,654,337 www.genscolabs.com" ], "active_ingredient_table": [ "
DRUG FACTS PURPOSE
Aconitum Napellus 3X-HPUS Neuralgia
Arnica Montana 3X-HPUS Healing of Injured Tissue
Belladonna 4X-HPUS Inflammation
Bellis Perennis TINC-HPUS Bruising and Edema
Calendula Officinallis TINC-HPUS Analgesia
Chamomilla TINC-HPUS Tissue Healing
Echinacea Angustifolia TINC-HPUS Inflammation
Echinacea Purpurea TINC-HPUS Inflammation
Hamamellis Virginiana TINC-HPUS Hematomas
Hypericum Perforatum TINC-HPUS Neuropathic Pains
Millefolium TINC-HPUS Wound healing
Symphytum Officinale 4X-HPUS Neuropathy and Periostitus
Zingiber Officinale Inflammation
" ], "package_label_principal_display_panel": [ "NDC 35781-0230-0 WWW.GENSCOLABS.COM", "US PATENT #5,654,337 NDC 35781-0230-0 WWW.GENSCOLABS.COM", "Inflam-x Box", "Label", "Drug Facts" ], "indications_and_usage": [ "INFLAM-X PRO is a homeopathic topical analgesic gel that contains the ingredients listed below. Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions.It is an amber colored odorless gel for use externally to control inflammation and reduce pain." ], "set_id": "eae51745-f889-409a-ace6-86f3ca5d21d3", "id": "ab5093da-fe6e-437f-94bd-d233a3683967", "active_ingredient": [ "ACTIVE INGREDIENTS Aconitum Napellus 3X, Arnica Montana 3X, Belladonna 4X, Bellis Perennis 1X, Calendula Officinalis 1X, Chamomilla 1X, Echinacea Angustifolia 1X, Echinacea Purpurea 1X, Hamamelis Virginiana 1X, Hypericum Perforatum 1X, Millefolium 1X, Symphytum Officinale 3X, Zingiber Officinale 1X.", "DRUG FACTS PURPOSE Aconitum Napellus 3X-HPUS Neuralgia Arnica Montana 3X-HPUS Healing of Injured Tissue Belladonna 4X-HPUS Inflammation Bellis Perennis TINC-HPUS Bruising and Edema Calendula Officinallis TINC-HPUS Analgesia Chamomilla TINC-HPUS Tissue Healing Echinacea Angustifolia TINC-HPUS Inflammation Echinacea Purpurea TINC-HPUS Inflammation Hamamellis Virginiana TINC-HPUS Hematomas Hypericum Perforatum TINC-HPUS Neuropathic Pains Millefolium TINC-HPUS Wound healing Symphytum Officinale 4X-HPUS Neuropathy and Periostitus Zingiber Officinale Inflammation" ] }, { "effective_time": "20140925", "inactive_ingredient": [ "Inactive ingredients Tablets: acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake Suppositories: hydrogenated vegetable oil" ], "purpose": [ "part of a bowel cleansing regimen in preparing patients for surgery preparing the colon for x-ray or endoscopic examination" ], "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 unless directed by a doctor tablets, if you cannot swallow without chewing When using this product suppository is for rectal use only do not take tablets within 1 hour after taking an antacid or milk do not chew or crush tablet(s) it may cause stomach discomfort, faintness, rectal burning or cramps Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. 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 suppository is for rectal use only do not take tablets within 1 hour after taking an antacid or milk do not chew or crush tablet(s) it may cause stomach discomfort, faintness, rectal burning or cramps" ], "spl_product_data_elements": [ "Dulcolax bisacodyl Dulcolax bisacodyl BISACODYL BISACODYL ACACIA CARNAUBA WAX CELLACEFATE STARCH, CORN DIBUTYL PHTHALATE DOCUSATE SODIUM GELATIN GLYCERIN KAOLIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN SHELLAC POLYETHYLENE GLYCOLS POVIDONE PROPYLPARABEN SODIUM BENZOATE SORBITAN MONOOLEATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX 12; Dulcolax bisacodyl BISACODYL BISACODYL HYDROGENATED COCONUT OIL HYDROGENATED PALM KERNEL OIL" ], "ask_doctor": [ "Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions read the entire label and directions at least 24 hours in advance of examination follow each step and complete all instructions or the entire x-ray or the endoscopic examination may have to be repeated" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information store at 20-25°C (68-77°F) protect from excessive humidity" ], "do_not_use": [ "Do not use unless directed by a doctor tablets, if you cannot swallow without chewing" ], "active_ingredient_table": [ "
Active ingredient Purpose
Bisacodyl USP 5 mg (in each tablet) .................................... Stimulant laxative
Bisacodyl USP 10 mg (in each suppository) ......................... Stimulant laxative
" ], "package_label_principal_display_panel": [ "Dulcolax Suppository Kit" ], "indications_and_usage": [ "Uses part of a bowel cleansing regimen in preparing patients for surgery preparing the colon for x-ray or endoscopic examination" ], "set_id": "f673f6e2-08a0-40cf-9d48-86e8108f7788", "id": "a14b2f43-250e-8014-3578-310c6d8c291b", "active_ingredient": [ "Drug Facts Active ingredient Purpose Bisacodyl USP 5 mg (in each tablet) .................................... Stimulant laxative Bisacodyl USP 10 mg (in each suppository) ......................... Stimulant laxative" ] } ] }