Label: ACETAMINOPHEN bar, chewable
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- NDC Code(s): 50488-4160-1
- Packager: Alexso, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 27, 2020
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 10 doses in 24 hours
- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
- adults has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Take under the supervision of a physician if you have liver disease, taking a blood thinning drug called warfarin, or have a history of high blood pressure or diabetes.
- adult takes more than 4,000 mg of acetaminophen in 24 hours
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DIRECTIONS
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- take 4 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
- chew each soft chew thoroughly before swallowing
- do not take more than 20 soft chews in 24 hours
- do not take for more than 10 days unless directed by a physician
Children 6 to 11 years:
- take 2 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
- chew each soft chew thoroughly before swallowing
- do not take more than 10 soft chews in 24 hours
- do not take for more than 5 days unless directed by a physician
Children under 6 years: ask a physician
- take 4 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
- OTHER INFORMATION
- Inactive ingredients:
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen bar, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-4160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK) CARRAGEENAN (UNII: 5C69YCD2YJ) MALTITOL (UNII: D65DG142WK) SUCROSE (UNII: C151H8M554) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) NEOTAME (UNII: VJ597D52EX) MALTODEXTRIN (UNII: 7CVR7L4A2D) CORN SYRUP (UNII: 9G5L16BK6N) WATER (UNII: 059QF0KO0R) Product Characteristics Color ORANGE Score no score Shape ROUND Size 25mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-4160-1 14 in 1 CONTAINER; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 11/01/2019 Labeler - Alexso, Inc (963338061)
