Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55315-531-12, 55315-531-57 - Packager: FRED'S, 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 24, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts ore than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-8000-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
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do not take more than directed
(see overdose warning) - adults and children 12 years and over
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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do not take more than directed
- Other information
- Inactive ingredients
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Principal display panel
FRED'S®
Extra Strength Non-Aspirin
Pain Reliever
Pain Reliever/Fever ReducerAcetaminophen
EZ Tabs
100 Tablets - 500 mg each
Tested Against The Active Ingredient In:
Extra Strength TYLENOL® EZ TABS††This product is not manufactured or distributed McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® EZ Tabs.
50844 REV0213D53112
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Fred's 44-531
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-531 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;531 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-531-57 1 in 1 CARTON 1 125 in 1 BOTTLE 2 NDC:55315-531-12 1 in 1 CARTON 2 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/11/2005 Labeler - FRED'S, INC. (005866116) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55315-531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55315-531)