ACETAMINOPHEN- acetaminophen tablet, 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 325 mg Chewable Gels
Alexso, Inc.
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Acetaminophen 325 mg Chewable Gels
DRUG FACTS
ACTIVE INGREDIENT
Acetaminophen 325mg
PURPOSE
Pain reliever/fever reducer
USES
Acetaminophen 325mg Chewable Gel 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:
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours
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- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
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- adults has 3 or more alcoholic drinks every day while using this product
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- skin reddening
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- blisters
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- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include
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
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- with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
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- 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.
Stop use and ask a doctor if
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- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, consult a physician or health professional before use.
KEEP OUT OF REACH OF CHILDREN
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DIRECTIONS
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
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- take 2 chewable gels every 4 to 6 hours while symptoms last or as directed by a physician
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- chew each chewable gel thoroughly before swallowing
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- do not take more than 10 chewable gels in 24 hours
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- do not take for more than 10 days unless directed by a physician
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- take 1 chewable gel every 4 to 6 hours while symptoms last or as directed by a physician
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- chew each chewable gel thoroughly before swallowing
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- do not take more than 5 chewable gels in 24 hours
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- do not take for more than 5 days unless directed by a physician
Children 6 to 11 years:
Children under 6 years: ask a physician
OTHER INFORMATION
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each chewable gel contains: sodium 7.44 mg.
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each chewable gel contains: sugar 2g.
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- 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.
HOW SUPPLIED
Acetaminphen 325mg Chewable Gel is supplied in the following dosage form:
Fourteen (14) chewable gels per container
Made in USA
Rx Only
Manufactured for:
Alexso, Inc.
2317 Cotner Ave
Los Angeles, CA 90064
NDC: 50488-4325-1
Size: 14 Chewable Gels
PRINCIPAL DISPLAY PANEL
Acetaminophen 325 mg Chewable Gels
14 Orange Flavored Gummies
NDC: 50488-4325-1