ACETAMINOPHEN- acetaminophen bar, chewable
Alexso, Inc
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.
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Acetaminophen 160 mg Chewable Gels
Acetaminophen 160 mg Soft Chews
Alexso, Inc.
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Acetaminophen 160 mg Soft Chews
DRUG FACTS
USES
Acetaminophen 160mg Soft Chews is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.
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.
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
OTHER INFORMATION
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each soft chew contains: sodium 7.44 mg.
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each soft chew contains: sugar 2g.
- store in a cool dry place between 20-25°C (68-77°F).
Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive ingredients:
hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.
| ACETAMINOPHEN
acetaminophen bar, chewable |
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| Labeler - Alexso, Inc (963338061) |