ACETAMINOPHEN tablet, coated

ACETAMINOPHEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each caplet)

acetaminophen 500 mg

INACTIVE INGREDIENT

inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*stearic acid, titanium dioxide
*may contain

PURPOSE

PAIN RELIEVER - FEVER REDUCER

DOSAGE & ADMINISTRATION

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 6 caplets in 24 hours

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

children under 12 years: ask a doctor.

INDICATIONS & USAGE

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.

WARNINGS

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-755
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
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-755-88	1000 in 1 PACKAGE	01/03/2020
1	NDC: 49035-755-50	500 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/03/2020

Labeler - WAL-MART STORES INC (051957769)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(49035-755)