Label: ACETAMINOPHEN- acetaminophen extra strength tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 71399-8027-1, 71399-8027-2 - Packager: Akron Pharma 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 July 5, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active ingredient (in each tablet)Acetaminophen 500 mg
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PurposePain Reliever/Fever Reducer
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UsesTo reduce fever and for the temporary relief of minor aches and pains due to: • headache - • muscular aches - • backache - • minor pain of arthritis - • the common cold - • toothache - • premenstrual and ...
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WarningsLiver 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 5 doses in 24 ...
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Directions - do not take more than directed (see overdose warning)adults & children 12 years and over - take 2 tablets every 6 hours while symptoms last - do not take more than 6 tablets in 24 hours - do not use for more than 10 days unless directed by a ...
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Other informationstore at temperature 15° to 30°C (59° to 86°F)
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Inactive Ingredients:pregelatinized starch, microcrystalline cellulose, povidone (PVP K-30), colloidal silicon dioxide, croscarmellose sodium, stearic acid.
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Questions or Comments?Call toll-free 1-877-225-6999 - Manufactured for - Akron Pharma, Inc., 373 RT US46 W Building E, Suite 117, Fairfeld, NJ - 07004 - * This product is not manufactured or distributed by McNeal ...
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