- 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)