ACETAMINOPHEN  - acetaminophen tablet, film coated 
TIME CAP LABORATORIES, INC

Acetaminophen 500 mg

PURPOSE:  Pain Reliever - fever reducer

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

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

Warnings;
Liver warning:  This product contains acetaminophen.  Severe liver damage may occur if you take:more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage.  in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over:  take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; 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 dose (overdosage) of acetaminophen and may cause liver damage

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE

** MAY CONTAIN THIS INGREDIENT

ACETAMINOPHEN  acetaminophen  tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-342 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 CARNAUBA WAX   FD&C RED NO. 40   HYPROMELLOSES   POLYETHYLENE GLYCOL 400   POLYETHYLENE GLYCOL 8000   POVIDONE   STARCH, CORN   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   SUCRALOSE   TITANIUM DIOXIDE

Product Characteristics Color red Score no score Shape ROUND Size 11mm Flavor Imprint Code TCL342 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-342-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 49483-342-10 1000 TABLET In 1 BOTTLE, PLASTIC None 3 49483-342-00 100000 TABLET In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/01/2023

Labeler - TIME CAP LABORATORIES, INC (037052099)

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

Revised: 05/2012TIME CAP LABORATORIES, INC