{
"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": "2024-03-27",
"results": {
"skip": 0,
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"results": [
{
"effective_time": "20151231",
"inactive_ingredient": [
"INACTIVE INGREDIENTS: Acetic Acid, Aluminum Acetate, Aluminum Oxide, Glycerin, Policosanol."
],
"contraindications": [
"CONTRAINDICATIONS: Hypersensitivity to any of the components or substances related to Otic Care Otic Solution. In case of tympanic membrane perforation or discharge."
],
"precautions": [
"PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals or humans have been conducted. Pregnancy Category C: Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Consult your physician. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Consult your physician."
],
"pregnancy": [
"Pregnancy Category C: Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Consult your physician."
],
"warnings": [
"WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN."
],
"nursing_mothers": [
"Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Consult your physician."
],
"spl_product_data_elements": [
"Otic Care Antipyrine and Benzocaine Antipyrine, Benzocaine ANTIPYRINE ANTIPYRINE BENZOCAINE BENZOCAINE ALUMINUM ACETATE ALUMINUM OXIDE GLYCERIN ERICERUS PELA POLYCOSANOL ACETIC ACID"
],
"description": [
"DESCRIPTION: Each mL contains: Antipyrine...........................................5.4% Benzocaine........................................1.4% TOPICAL ANESTHETIC AND ANALGESIC: Otic Care Otic Solution contains antipyrine, benzocaine, acetic acid, aluminum acetate, aluminum oxide, glycerin and policosanol. The solution congeals at 0°C (32°F) but returns to normal consistency, unchanged at room temperature. The structures of the components are: image description"
],
"openfda": {},
"version": "2",
"dosage_and_administration": [
"DOSAGE AND ADMINISTRATION: Warm to body temperature (37°C or 98°F) by holding the bottle in the hand for a few minutes. To apply eardrops, wash your hands first. To avoid contamination do not touch the dropper or let it touch your ear or any surface. Instill Otic Care Otic Solution by tilting the affected ear upward, holding the dropper directly over the ear, and placing the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted about two minutes. Moisten a cotton pledget with Otic Care Otic Solution and insert into the opening of the ear canal. Repeat every one to two hours until pain and congestion is relieved. REMOVAL OF EARWAX: Instill Otic Care Otic Solution three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal. Otic Care Otic Solution is useful for drying out the canal or relieving discomfort. Before and after removal of cerumen, insert a cotton pledget saturated with Otic Care Otic Solution into the meatus. If swallowed or overdose is suspected, contact your local Poison Control Center or emergency room immediately. You may call US National Poison Hotline at 1-800-222-1222. Note: Do not rinse dropper after use. Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly. Protect the solution from light and heat, and do not use if it is brown or contains a precipitate. DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION."
],
"adverse_reactions": [
"ADVERSE REACTIONS: Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088."
],
"storage_and_handling": [
"STORAGE: Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed."
],
"how_supplied": [
"HOW SUPPLIED: 14 mL of Otic Care Otic Solution ear drops are supplied in a white plastic bottle with separate dropper with screw cap attachment and package insert, NDC 59088-864-02."
],
"package_label_principal_display_panel": [
"Image Label image description"
],
"indications_and_usage": [
"INDICATIONS AND USAGE: Acute otitis media of various etiologies: Rapid pain relief and reduction of inflammation in the congestive and serous stages of otitis media. Adjuvant therapy during systemic antibiotic administration. Removal of earwax: Facilitates the removal of excessive or impacted earwax."
],
"clinical_pharmacology": [
"CLINICAL PHARMACOLOGY: Otic Care Otic Solution combines the properties of acetic acid, policosanol and aluminum acetate with the analgesic action of antipyrine and the local anesthetic action of benzocaine to relieve pressure, reduce inflammation and congestion, and alleviate pain and discomfort in acute otitis media. Does not blanch the tympanic membrane or mask the landmarks and therefore, does not distort the otoscopic picture."
],
"set_id": "02eea871-d176-4790-9bc7-c8a5da423532",
"carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [
"Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals or humans have been conducted."
],
"id": "e6ef239d-d975-4536-9242-0a11348cfa66"
},
{
"effective_time": "20141010",
"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)"
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 1-866-923-4914"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information do not use if carton is opened, or if imprinted safety seal is broken or missing. see bottom panel for expiration date store between 20° to 25°C (68° to 77°F)"
],
"indications_and_usage": [
"Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"
],
"set_id": "039b6b47-48d0-4a00-a927-c1ddebcf887f",
"id": "689dc410-a14c-42c1-b295-a76a5e47612b",
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."
],
"active_ingredient": [
"Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg"
],
"dosage_and_administration_table": [
"
adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose"
],
"warnings": [
"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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. (1-800-222-1222)"
],
"spl_product_data_elements": [
"Childrens 24 Hour Allergy Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose colorless to slightly yellow Sugar Free"
],
"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
],
"openfda": {},
"version": "2",
"dosage_and_administration": [
"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
],
"spl_unclassified_section": [
"Drug Facts",
"DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544"
],
"stop_use": [
"Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."
],
"do_not_use": [
"Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 41250-106-08 Compare to Children's Zyrtec ® active ingredient* meijer ™ Sugar Free 2 Years and Older Children's 24 Hour Allergy Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine Bubble Gum Flavor DYE-FREE Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing / Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Dosing Cup Included 4 FL OZ (120 mL) PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton"
]
},
{
"effective_time": "20140407",
"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)."
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 1-800-200-6313"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F)"
],
"indications_and_usage": [
"Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"
],
"set_id": "045cfd34-271d-48ef-a92e-7c13b34253a3",
"id": "5f7f713f-89c8-40ac-b47c-30619ce0c05c",
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."
],
"active_ingredient": [
"Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg"
],
"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose"
],
"warnings": [
"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222)."
],
"spl_product_data_elements": [
"Leader Childrens Allergy Relief Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose colorless to slightly yellow"
],
"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
],
"openfda": {},
"version": "2",
"dosage_and_administration": [
"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
],
"spl_unclassified_section": [
"Drug Facts",
"DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017"
],
"stop_use": [
"Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."
],
"do_not_use": [
"Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton LEADER ® NDC 37205-591-26 Compare to Children's Zytrec ® active ingredient † CHILDREN'S Allergy Relief Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine 24 Hour Sugar Free Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Indoor & Outdoor Allergies Bubble Gum Flavor Ages two years and older ● SATISFACTION ● GUARANTEED 4 FL OZ (120 mL) Principal Display Panel - 120 mL Bottle Carton"
]
},
{
"effective_time": "20121203",
"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)."
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 1-866-923-4914"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F)"
],
"indications_and_usage": [
"Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"
],
"set_id": "0bca5f76-db36-4256-99d5-1461bb6ae05c",
"id": "fa33ef6f-3f62-4ff7-a6e8-ef431f4f209d",
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."
],
"active_ingredient": [
"Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg"
],
"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose"
],
"warnings": [
"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222)."
],
"spl_product_data_elements": [
"Childrens all day allergy Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate sucrose colorless to slightly yellow"
],
"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
],
"openfda": {},
"version": "1",
"dosage_and_administration": [
"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
],
"spl_unclassified_section": [
"Drug Facts",
"Another Quality Product Distributed by McKesson One Post Street, San Francisco, CA 94104"
],
"stop_use": [
"Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."
],
"do_not_use": [
"Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton sunmark ® COMPARE TO CHILDREN'S ZYRTEC ® ACTIVE INGREDIENT* NDC 49348-972-34 Children's all day allergy Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine 2 years & older indoor & outdoor allergies 24 hour relief of: sneezing, runny nose itchy, watery eyes itchy throat or nose dosing cup included GRAPE FLAVOR 4 FL OZ (120 mL) PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton"
]
},
{
"effective_time": "20120313",
"inactive_ingredient": [
"INACTIVE INGREDIENTS Children’s Advil Suspension Fruit Flavor artificial flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children’s Advil Suspension Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children’s Advil Suspension Blue Raspberry Flavor artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum",
"Children’s Advil Suspension Fruit Flavor artificial flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum",
"Children’s Advil Suspension Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum",
"Children’s Advil Suspension Blue Raspberry Flavor artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum"
],
"purpose": [
"PURPOSE Fever reducer/Pain reliever"
],
"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.",
"Enter section text here"
],
"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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the child has problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma taken a diuretic Ask a doctor or pharmacist before use if the child is taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug 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 the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.",
"DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directe d do not give longer than 10 days, unless directed by a doctor (see WARNINGS ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. repeat dose every 6-8 hours , if needed do not use more than 4 times a day measure only with the blue dosing cup provided. Blue dosing cup to be used with Children’s Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. Dosing Chart Weight (lb) Age (yr) Dose (tsp) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 1 tsp 36-47 lb 4-5 yr 1½ tsp 48-59 lb 6-8 yr 2 tsp 60-71 lb 9-10 yr 2½ tsp 72-95 lb 11 yr 3 tsp"
],
"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 OR COMMENTS? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional"
],
"spl_product_data_elements": [
"Childrens ADVIL ibuprofen ibuprofen ibuprofen carboxymethylcellulose sodium citric acid monohydrate Translucent red"
],
"ask_doctor": [
"Ask a doctor before use if the child has problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems not been drinking fluids lost a lot of fluid due to vomiting or diarrhea high blood pressure heart or kidney disease asthma taken a diuretic"
],
"openfda": {},
"version": "1",
"dosage_and_administration": [
"Enter section text here"
],
"spl_unclassified_section": [
"DRUG FACTS",
"OTHER INFORMATION Children’s Advil Suspension Fruit Flavor; Children’s Advil Suspension Grape Flavor each teaspoon contains: sodium 3 mg one dose lasts 6-8 hours store at 20-25°C (68-77°F) see bottom of box for lot number and expiration date Children’s Advil Suspension Blue Raspberry Flavor each teaspoon contains: sodium 10 mg one dose lasts 6-8 hours store at 20-25°C (68-77°F) see bottom of box for lot number and expiration date"
],
"stop_use": [
"Stop use and ask a doctor if the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. stomach pain or upset gets worse or lasts the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear"
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"do_not_use": [
"Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery"
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under 24 lb | under 2 yr | ask a doctor |
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36-47 lb | 4-5 yr | 1½ tsp |
48-59 lb | 6-8 yr | 2 tsp |
60-71 lb | 9-10 yr | 2½ tsp |
72-95 lb | 11 yr | 3 tsp |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
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children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and over | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
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children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. |
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consumers with liver or kidney disease | ask a doctor |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
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children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. |
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],
"pregnancy_or_breast_feeding": [
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"Other information do not use if carton is opened or if imprinted safety seal is broken or missing see bottom panel for lot number and expiration date store between 20° to 25°C (68° to 77°F)"
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" adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
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" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and over | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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"Questions or comments? 1-877-932-7948"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use."
],
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"Other information • do not use if carton is opened, or if printed neckband is broken or missing • store between 20° to 25°C (68° to 77°F)"
],
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"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"
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"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and over | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients artificial cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose"
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"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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. (1-800-222-1222)"
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"spl_product_data_elements": [
"equaline all day allergy cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ACETIC ACID GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM ACETATE SUCROSE Mint"
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"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
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"version": "2",
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"Directions • use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
],
"stop_use": [
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"do_not_use": [
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"package_label_principal_display_panel": [
"Package/Label Principal Display Panel compare to Children’s Zyrtec® active ingredient children’s all day allergy cetirizine hydrochloride oral solution 1 mg/mL (antihistamine) indoor & outdoor allergies 24 hour relief of: runny nose sneezing itchy, watery eyes itchy throat or nose DYE FREE 2 years & older cherry flavor dosing cup included 4 FL OZ (118 mL) Equaline Children's All Day Allergy Image 1 Equaline Children's All Day Allergy Image 2"
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"inactive ingredients acetic acid, deionized water, benzyl alcohol, C13-14 isoparaffin, ethylhexylglycerin, laureth-y, parfum, phenoxyethanol, polyacrylamide, polysorbate-20, SD-alcohol 40B"
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"keep_out_of_reach_of_children": [
"Keep this and all medications out of the reach of children"
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"Warnings do not use on children under two years of age except under the advice and supervision of a doctor. stop use and ask a doctor if irritation occurs, if condition worsens, or there is not improvement within four weeks. for externam use only avoid contact with eyes, scalp, vagina, penis, scortum and anus do not ingest do not use on open wounds in case of accidental ingestion, contacgt a physician, emergency medical do not use if you are know to be sensitive to any of the ingredients in this product"
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"openfda": {},
"version": "3",
"dosage_and_administration": [
"Directions shake well before using clean and dry affected areas apply twice per day, or as recommended by your doctor, with the brush applicator, a thin layer of the product to the affected areas"
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"storage_and_handling": [
"other information store at controlled room temperature 15-30C (59-86F) protect from heat keep from freezing. if freezing occurs, thaw out at room temperature and shake well to mix contents back to a solution."
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"Uses antifungal drying agent antibacterial drying agent is indicated in the treatment of most fungi, athlete's foot, rignworm, jock itch, candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes, epidemophyton floccsum is indicated for the treatment of most bacteria, gram postivie bacteria is indicated for certain methicillin-resistant saphylococcus aureus (MRSA) isolates is indicated for most coagulase-negative staphylococci, beta-hemolytic streptococci, corynebaterium species, clostridium species, anaerobic gram-negative bacilli"
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"active_ingredient": [
"active ingredient miconazole nitrate triclosan"
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"inactive_ingredient": [
"Inactive Ingredients Inactive Ingredients water, corn starch modified, pentylene glycol, lactic acid, sodium hyaluronate, ammonium hydroxide,, bisabolol, dicetly phosphate, sodium PCA, allantoin, farnesol, fragrance, magnesium aluminum silicate, panthenol, retinyl palmitate, tetrahexyldecyl ascorbate, tocopheryl acetate, palmitic acid, xanthan gum, glycine soja (soybean) seed extract, tocopherol, aloe barbadensis leaf juice, sodium C8-16 isoalkylsuccinyl wheat sulfonate, ceteth-10 phosphate, niacinamide, potassium sorbate,sodium benzoate, spiraea ulmaria extract, butylene glycol, acetic acid, ceramide 2, lecithin, methylisothialinone, yogurt extract, bentane, cinnamomum cassia bark extract, arginine, poterium officinale root extract, saccharomyces lysate extract, zingiber officinale (ginger) root extract, sorbitol, alanine, glycine, lysine, proline, serine, threonine, PEG-40 stearate, glutamic acid, cetearyl alcohol, dimethicone, PPG-15 stearyl ether, cholesterol, propylene glycol, camellia oleifera leaf extract, disodium EDTA, retinol"
],
"purpose": [
"Purposes Purposes Acne treatment"
],
"keep_out_of_reach_of_children": [
"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."
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"warnings": [
"Warnings Warnings For external use only Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor."
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],
"other_safety_information": [
"Other information Other information Reports on serious side effects associated with the use of the product can be sent to: 75 Varick St. 10th Floor, New York, New York 10013"
],
"openfda": {},
"version": "1",
"dosage_and_administration": [
"Directions Directions Apply to cleansed skin Cover the affected area with a thin layer 1 to 2 times a day If bothersome dryness or peeling occurs, reduce use to once a day For optimal efficacy, use with No 'Zit' Sherlock acne system"
],
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"Package Label bliss from our spa to your skin PROBIOTIC POWERED no 'zit' sherlock acne system oil control moisturizer clears clogged complexions with 2% salicylic acid probiotics defend against bacteria calms and soothes skin why we're 'pro' probiotics Probiotics (like the yogurt and meadowsweet extract found in this moisturizer) are 'beneficial' bacteria similar to those found in your own body. They help boost skin's natural defenses against bacteria and create a healthier environment. bliss dist Bliss New York NY 10013 USA London HA3 6DO UK 1003-02250 Made in USA blissworld.com 50mL/1.7 fl oz 1001-02250-208 bliss no zit sherlock1 label"
],
"indications_and_usage": [
"Uses Uses helps keep skin clear of blackheads helps prevent new acne blemishes penetrates pores to eliminate most acne pimples"
],
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"id": "638f3c5c-ea90-4ca1-ab47-418260f4f3e3",
"active_ingredient": [
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]
},
{
"effective_time": "20140131",
"purpose": [
"Purpose Antihistamine"
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"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)"
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"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? 1-800-632-6900"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
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"Other information do not use if carton is opened, or if imprinted safety seal is broken or missing. see bottom panel for expiration date store between 20° to 25°C (68° to 77°F)"
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"indications_and_usage": [
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"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose"
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"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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. (1-800-222-1222)"
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"spl_product_data_elements": [
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"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
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"openfda": {},
"version": "1",
"dosage_and_administration": [
"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
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"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton COMPARE TO the active ingredient in CHILDREN'S ZYRTEC ® *See back panel NDC 30142-102-08 Kroger ® FROM OUR FAMILY TO YOURS 2 YEARS & OLDER Children's All Day Allergy Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine SUGAR FREE 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye Free 4 FL OZ (120 mL) 24 HOUR • Our Pharmacists • Recommend Grape Flavor Principal Display Panel - 120 mL Bottle Carton"
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{
"effective_time": "20130124",
"purpose": [
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"keep_out_of_reach_of_children": [
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"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 248-449-9300"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F)"
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"indications_and_usage": [
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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"inactive_ingredient": [
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"ask_doctor": [
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"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
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"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton QC QUALITY CHOICE ® NDC 63868-093-08 Compare to the active ingredient in Children's ZYRTEC ® * children's Allergy Relief Cetirizine Hydrochloride Oral Solution, 1 mg/mL Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: Runny Nose | Sneezing Itchy, watery eyes Itchy throat or nose 2 Yrs. & older Sugar Free Grape Flavor Dosing Cup Included 4 FL OZ (120 mL) Principal Display Panel - 120 mL Bottle Carton"
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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"inactive_ingredient": [
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},
{
"effective_time": "20101008",
"inactive_ingredient": [
"Inactive Ingredient Hydroxypropyl Methylcellulose, Glacial acetic acid, Pectin, Purified Water, Glycerin, Calcium Gluconate, Sucrose Esters of fatty acids"
],
"purpose": [
"Purpose vitamin and mineral"
],
"keep_out_of_reach_of_children": [
"Keep out of Reach of Children Stop use and ask a doctor if - chest pain, rapid heartbeat, or dizziness occurs - your hands or feet swell - breast tenderness - menstrual irregularities - 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."
],
"warnings": [
"Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Ginseng Ask a doctor before use if you have -heart disease -high fever -diabetes -headaches and sleep problems -gastrointestinal problems Ask a doctor or pharmacist before use if you are taking antibiotics."
],
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"Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG ASIAN GINSENG ASIAN GINSENG ACETIC ACID WATER PECTIN SUCROSE GLYCERIN CALCIUM GLUCONATE HYPROMELLOSE 2208 (100 MPA.S) yellow brown ;"
],
"openfda": {},
"version": "2",
"dosage_and_administration": [
"Dosage & Administraion Adults and children 15 years and older; take 2 capsules with warm or cool water. 3 times daily. Children under 15 years ; take half dosage for adults"
],
"package_label_principal_display_panel": [
"Korea Ginseng Corporation Cheong-Kwan-Jang Korean HongSam Powder Capsule Net WT. 3.17 OZ (90g) 180capsules image of carton label"
],
"indications_and_usage": [
"Indication & Usage Uses - Supports immune system - Improves the health of people recovering from illness. Other information - before use, read all information on carton and enclosed booklet. - store at controlled room temperature 1 to 30 ℃ - do not store in hot location or expose to sunlight."
],
"set_id": "b7233ede-c7a1-43c9-b793-58929a380b2c",
"id": "44f13ab9-0616-41f9-bd19-d0f75e8d558c",
"active_ingredient": [
"Drug Facts Active Ingredient Asian Ginseng USP 500mg"
]
},
{
"effective_time": "20130403",
"inactive_ingredient": [
"Water; Hydroxyethyl Cellulose; Alkyl Polyglucoside; C12-C15 Pareth-3; 1-Ocatadecanaminium,N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride; Polyhexamethylene Biguanide; Acetic Acid; Citronellol; Ammonia; Glycerin; AloeBarbadensis (Aloe) Leaf Extract; D and C Green No.5"
],
"purpose": [
"Antiseptic"
],
"keep_out_of_reach_of_children": [
"Keep out of reach on children Children must be supervised in use of this product"
],
"warnings": [
"For external use only Do not use in ears or mouth"
],
"when_using": [
"When using this product do not use in ears or mouth Avoid contact with eyes In case of eye contact, rinse eyes thoroughly with water"
],
"spl_product_data_elements": [
"GFS BioProtect Hand Sanitizer Aloe Vera Benzalkonium Chloride BENZALKONIUM CHLORIDE Benzalkonium Water HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE C12-15 PARETH-12 POLYAMINOPROPYL BIGUANIDE Acetic Acid CAPRYLYL GLUCOSIDE .BETA.-CITRONELLOL, (+/-)- AMMONIA GLYCERIN ALOE VERA LEAF D&C Green No. 5"
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"BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with Water,Hydroxyethyl Cellulose, Alkyl Polyglucoside, C12-C15 Pareth-3, 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, Polyhexamethylene Biguanide, Acetic Acid, Citronellol, Ammonia, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs."
],
"openfda": {},
"version": "8",
"dosage_and_administration": [
"Apply a small amount into your palm and throughly spread on both hands Rub into skin until dry"
],
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"Hand sanitizer to help decrease bacteria on skin Recommended for repeated use"
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"set_id": "b79ac717-24dc-461f-9b97-60a41c2af565",
"id": "a99bdb46-8246-4ff6-a5e1-5b25f896b06b",
"active_ingredient": [
"Benzalkonium Chloride 0.13%.............................................Antiseptic"
]
},
{
"effective_time": "20110830",
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"Water; Hydroxyethyl Cellulose; Alkyl Polyglucoside; C12-C15 Pareth-3; 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride; Polyhexamethylene Biguanide; Acetic Acid; Citronellol; Ammonia; Glycerin; Aloe Barbadensis (Aloe) Leaf Extract; D and C Green No.5"
],
"purpose": [
"Antispetic"
],
"keep_out_of_reach_of_children": [
"Keep out of reach on children Children must be supervised in use of this product"
],
"warnings": [
"For external use only Do not use in ears or mouth"
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"when_using": [
"When using this product do not use in ears or mouth Avoid contact with eyes In case of eye contact, rinse eyes thoroughly with water"
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"spl_product_data_elements": [
"GFS BioProtect Aloe Vera Hand Sanitizer Benzalkonium Chloride Benzalkonium Chloride Benzalkonium Water HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE POLYAMINOPROPYL BIGUANIDE Acetic Acid CAPRYLYL GLUCOSIDE .BETA.-CITRONELLOL, (+/-)- AMMONIA GLYCERIN ALOE VERA LEAF D&C Green No. 5"
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"description": [
"BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with Water,Hydroxyethyl Cellulose, Alkyl Polyglucoside, C12-C15 Pareth-3, 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, Polyhexamethylene Biguanide, Acetic Acid, Citronellol, Ammonia, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs."
],
"openfda": {},
"version": "7",
"dosage_and_administration": [
"Apply a small amount into your palm and throughly spread on both hands Rub into skin until dry"
],
"general_precautions": [
"Review MSDS before handling the product"
],
"stop_use": [
"Stop use and ask a doctor if skin irritation or redness develops and persists for more than 72 hours"
],
"package_label_principal_display_panel": [
"Label BP_GEL"
],
"indications_and_usage": [
"Hand sanitizer to help decrease bacteria on skin Recommended for repeated use"
],
"set_id": "c65cd1af-9b9d-47d8-b877-ddc140145935",
"id": "2aba4076-9988-4268-a90f-89ba0b087f91",
"active_ingredient": [
"Benzalkonium Chloride 0.13%.............................................Antiseptic"
]
},
{
"effective_time": "20120530",
"inactive_ingredient": [
"Purified water, natural garlic oil,caramel, high fructose sucrose, menthol, ethanol, sodium citrate, citric acid, sodium benzoate, acetic acid"
],
"purpose": [
"EXPECTORANT -HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO MAKE COUGH MORE PRODUCTIVE"
],
"keep_out_of_reach_of_children": [
"Keep out reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
],
"warnings": [
"Ask a doctor before use if you have a cough that last or it is chronic such as occurs with smoking, asthma, chronic Bronchitis or emphysema. Stop use and ask doctor if a cough lasts for more than 7 days comes back or occurs when fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant of breast-feeding, ask a health professional before use."
],
"questions": [
"OTHER Information Shake well Before Use store at room temp (59F-86) imported and Distributed by: Bedessee Imports Ltd. Brooklyn, NY USA 11208 1-888-BEDESSEE 416-292-2400"
],
"spl_product_data_elements": [
"Liqufruta GUAIFENESIN GUAIFENESIN GUAIFENESIN WATER ALCOHOL SODIUM CITRATE GARLIC OIL CITRIC ACID MONOHYDRATE HIGH FRUCTOSE CORN SYRUP SODIUM BENZOATE CARAMEL MENTHOL ACETIC ACID"
],
"openfda": {},
"version": "7",
"dosage_and_administration": [
"do not take more than 6 doses in a 24-hour period AGE ......................................................DOSE Adults and Children 12 years and over .......2-4 teaspoonfuls(tsp) every 4 hours Children 6 years and under 12 years......... 1-2 teaspoonfuls(tsp) every 4 hours Children 2 years and under 6 years........... 1/2-1 teaspoonfuls(tsp) every 4 hours Under 2 years ........................................ask a doctor"
],
"package_label_principal_display_panel": [
"PDP CARTON"
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"indications_and_usage": [
"Loosens and Relieves Chest congestion"
],
"set_id": "ca244516-2177-438a-925f-6d84bd8985ee",
"id": "410a54c1-cdb4-465b-83f6-9986185f2ff1",
"active_ingredient": [
"GUAIFENESIN 50 MG/TEASPOON (5ML)"
]
},
{
"effective_time": "20111201",
"inactive_ingredient": [
"Water L-Menthol Glycerin Acetic Acid Sodium Acetate Camellia Sinensis leaf Extract Saccharin sodium Sodium benzoate Xylitol Poloxamer Citrus Medica Limonum Peel Oil Malic Acid Propolis Exxtract"
],
"purpose": [
"Anticavity Rinse"
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children."
],
"warnings": [
"Keep out of reach of children. Children under 7 years or younger must have parent supervision. If one drank a lot of amount, drink some milk and please go see a doctor."
],
"spl_product_data_elements": [
"Dental Clear Natural SODIUM FLUORIDE Sodium fluoride FLUORIDE ION Water LEVOMENTHOL GLYCERIN ACETIC ACID SODIUM ACETATE CAMELLIA SINENSIS ROOT SACCHARIN SODIUM DIHYDRATE SODIUM BENZOATE XYLITOL POLOXAMER 124 CITRUS LIMON FRUIT OIL MALIC ACID PROPOLIS WAX"
],
"openfda": {},
"version": "2",
"dosage_and_administration": [
"Rinse mouth with this Dental Clear Natural about 10 -15 ml for 30 seconds and expel."
],
"package_label_principal_display_panel": [
"Image"
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"indications_and_usage": [
"Use twice a day after brushing, meals, and before social occasions."
],
"set_id": "cc162a0e-b601-4466-9a4e-192985ee014a",
"id": "edb22a90-fd3a-4510-aa55-af050daf0220",
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"Sodium Fluoride (0.05%) Anticavity Rinse Keep out of reach of children. Children under 7 years or younger must have parent supervision. If one drank a lot of amount, drink some milk and please go see a doctor. Keep out of reach of children. Use twice a day after brushing, meals, and before social occasions. Rinse mouth with this Dental Clear Natural about 10 -15 ml for 30 seconds and expel. Water L-Menthol Glycerin Acetic Acid Sodium Acetate Camellia Sinensis leaf Extract Saccharin sodium Sodium benzoate Xylitol Poloxamer Citrus Medica Limonum Peel Oil Malic Acid Propolis Exxtract"
]
},
{
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"inactive_ingredient": [
"Water; Hydroxyethyl Cellulose; Alkyl Polyglucoside; C12-C15 Pareth-3; 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride; Polyhexamethylene Biguanide; Acetic Acid; Citronellol; Ammonia; Glycerin; Aloe Barbadensis (Aloe) Leaf Extract; D and C Green No.5"
],
"purpose": [
"Antispetic"
],
"keep_out_of_reach_of_children": [
"Keep out of reach on children Children must be supervised in use of this product"
],
"warnings": [
"For external use only Do not use in ears or mouth"
],
"when_using": [
"When using this product do not use in ears or mouth Avoid contact with eyes In case of eye contact, rinse eyes thoroughly with water"
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"spl_product_data_elements": [
"GFS BioProtect Aloe Vera Hand Sanitizer Benzalkonium Chloride Benzalkonium Chloride Benzalkonium Water HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE POLYAMINOPROPYL BIGUANIDE Acetic Acid CAPRYLYL GLUCOSIDE .BETA.-CITRONELLOL, (+/-)- AMMONIA GLYCERIN ALOE VERA LEAF D&C Green No. 5"
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"description": [
"BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with Water,Hydroxyethyl Cellulose, Alkyl Polyglucoside, C12-C15 Pareth-3, 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, Polyhexamethylene Biguanide, Acetic Acid, Citronellol, Ammonia, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs."
],
"openfda": {},
"version": "8",
"dosage_and_administration": [
"Apply a small amount into your palm and throughly spread on both hands Rub into skin until dry"
],
"general_precautions": [
"Review MSDS before handling the product"
],
"stop_use": [
"Stop use and ask a doctor if skin irritation or redness develops and persists for more than 72 hours"
],
"package_label_principal_display_panel": [
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"indications_and_usage": [
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"active_ingredient": [
"Benzalkonium Chloride 0.13%.............................................Antiseptic"
]
},
{
"effective_time": "20130312",
"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)."
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 248-449-9300"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F)"
],
"indications_and_usage": [
"Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"
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"set_id": "e0fa6eae-9589-423f-b251-9e0bd9235bb9",
"id": "c07a584b-051e-4350-a1ee-052d0e281ebc",
"ask_doctor_or_pharmacist": [
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"active_ingredient": [
"Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg"
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"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose"
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"warnings": [
"Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222)."
],
"spl_product_data_elements": [
"Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine ACETIC ACID GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM ACETATE ANHYDROUS SUCRALOSE colorless to slightly yellow Sugar Free"
],
"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
],
"openfda": {},
"version": "1",
"dosage_and_administration": [
"Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"
],
"spl_unclassified_section": [
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"© Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48376-0995"
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"stop_use": [
"Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."
],
"do_not_use": [
"Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."
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"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton QC QUALITY CHOICE ® NDC 63868-106-08 Compare to the active ingredient in Children's ZYRTEC ®* children's Allergy Relief Cetirizine Hydrochloride Oral Solution, 1 mg/mL Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: Runny Nose | Sneezing Itchy, watery eyes Itchy throat or nose 2 Yrs. & older Sugar Free Bubble Gum Flavor Dosing Cup Included 4 FL OZ (120 mL) Principal Display Panel - 120 mL Bottle Carton"
]
},
{
"effective_time": "20130122",
"purpose": [
"Purpose Antihistamine"
],
"keep_out_of_reach_of_children": [
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"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 1-866-923-4914"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use"
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"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F) Do not use if pouch is torn or damaged. Do not use if twist-off cap is removed or separated from vial. See side panel for lot number and expiration date"
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"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"
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"id": "a63774ea-cae4-4c0f-b6d3-9824139359ec",
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."
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"active_ingredient": [
"Active ingredient (in each 5 mL pre-filled vial) Cetirizine Hydrochloride 5 mg"
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"dosage_and_administration_table": [
" adults and children 6 years and over | 1 pre-filled (5 mL) or 2 pre-filled vials (10 mL) once daily depending upon severity of symptoms; do not take more than 2 pre-filled vials (10 mL) in 24 hours. |
adults 65 years and over | 1 pre-filled vial (5 mL) once daily; do not take more than 1 pre-filled vial (5 mL) in 24 hours. |
children under 6 years of age | ask a doctor |
Consumer with liver or kidney disease | ask a doctor |
"
],
"inactive_ingredient": [
"Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose."
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"spl_product_data_elements": [
"Wal-Zyr Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucrose colorless to slightly yellow"
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"ask_doctor": [
"Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."
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"openfda": {},
"version": "1",
"dosage_and_administration": [
"Directions medicine should be dispensed directly into mouth using the enclosed pre-filled vial(s). adults and children 6 years and over 1 pre-filled (5 mL) or 2 pre-filled vials (10 mL) once daily depending upon severity of symptoms; do not take more than 2 pre-filled vials (10 mL) in 24 hours. adults 65 years and over 1 pre-filled vial (5 mL) once daily; do not take more than 1 pre-filled vial (5 mL) in 24 hours. children under 6 years of age ask a doctor Consumer with liver or kidney disease ask a doctor"
],
"spl_unclassified_section": [
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"stop_use": [
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],
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"Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."
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"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 10 Vial Carton Well at Walgreens WALGREENS PHARMACIST RECOMMENDED ǂ NDC 0363-2088-05 NEW children's Wal-Zyr™ Cetirizine Hydrochloride Oral Solution 1 mg/mL / Antihistamine Allergy ● Alcohol free ● Gluten free ● 6 years & older Relieves: ● Sneezing ● Runny nose ● Itchy, watery eyes ● Itchy throat or nose INDOOR & OUTDOOR ALLERGIES 24 HOUR SYMPTOM RELIEF DYE FREE GRAPE FLAVOR 10 PRE-FILLED INDIVIDUAL VIALS Compare to Children's Zyrtec® active ingredient ǂǂ 0.17 FL OZ (5 mL) EACH PRINCIPAL DISPLAY PANEL - 10 Vial Carton"
]
},
{
"effective_time": "20121207",
"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 )"
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"
],
"questions": [
"Questions? Call 1-866-923-4914"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breastfeeding if breastfeeding: not recommended if pregnant: ask a health professional before use."
],
"storage_and_handling": [
"Other information store between 20° to 25°C (68° to 77°F)"
],
"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"
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"set_id": "e874dd97-0d4b-455a-b39d-b2e860d377cd",
"id": "d881cc46-4642-4167-8b1e-dfcb06ce8be4",
"ask_doctor_or_pharmacist": [
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],
"active_ingredient": [
"Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg"
],
"dosage_and_administration_table": [
" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
"
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" adults and children 6 years and over | 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. |
adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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"uses antifungal drying agent antibacterial drying agent is indicated in the treatment of most fungi athlete's foot (tinea pedis) ringworm (tinea corporis) jock itch (tinea cruris) candida albicans trichophyton rubrum malassezia furfur trichophyton mentagrophytes epidemophyton floccsum is indicated for the treatment of most bacteria gram positive bacteria (such as staphyloocccous aureus) is indicated for certain methicillin resistant saphylococcus aureus (MRSA) isolates is indicated for most coagulase-negative staphylococci beta hemolytic streptococci corynebacterium species clostridium species anaerobic gram-negative bacilli (such as bacteriodes fragilis)"
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"Other information store between 20° to 25°C (68° to 77°F)"
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adults 65 years and older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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