ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

ACETAMINOPHEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablets

acetaminophen 500 mg

INACTIVE INGREDIENT

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

PURPOSE

PAIN RELIEVER - FEVER REDUCER

WARNINGS

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

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.

ASK DOCTOR

Ask a doctor before use if you have liver disease.

STOP USE

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 DOCTOR/PHARMACIST

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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

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 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-341
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-341-01	100 in 1 BOTTLE, PLASTIC; 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	07/18/2011

Labeler - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(49483-341)