ACETAMINOPHEN  EXTRA STRENGTH - acetaminophen tablet, film coated 
TIME CAP LABS INC

Active Ingredient (in each tablets

acetaminophen 500 mg

Inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

PAIN RELIEVER - FEVER REDUCER

Warning:  Liver Warning:  This product contains acetaminophen. Severe liver damage may occur if you take:

    more than 8 caplets in 24 hours, which is the maximum daily amount.

    With other drugs containing acetaminophen

    3 or more alcoholic drinks every day while using this product

Uses:  temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps, temporarily reduces fever.

Ask a doctor before use if you have liver disease.

Stop use and ask a doctor if:

pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; new symptoms occur; redness or swelling is present. These could be signs of a serious condition.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Keep out of reach of children

If pregnant or breast-feeding, ask a health professional before use.

Directions:  Do not take more than directed (see overdose warning)

adults and children 12 years and over:  take 2 caplets every 4 to 6 hours while symptoms last

do not take more than 8 caplets in 24 hours

do not take for more than 10 days unless directed by a doctor

children under 12 years:  do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.

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ACETAMINOPHEN   EXTRA STRENGTH acetaminophen  tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-341 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES   MINERAL OIL   POVIDONE   STARCH, CORN   STEARIC ACID   TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code TCL341 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-341-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/18/2011

Labeler - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABS INC		037052099	manufacture

Revised: 07/2011TIME CAP LABS INC