ACETAMINOPHEN tablet, film coated

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Each tablet contains Acetaminophen 500 mg

PURPOSE

PURPOSE: Pain Reliever - fever reducer

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-342
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-342-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
2	NDC: 49483-342-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
3	NDC: 49483-342-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/01/2012

Labeler - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-342)