ACETAMINOPHEN by Granules Pharmaceuticals Inc. / Granules India Limited ACETAMINOPHEN tablet

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Granules Pharmaceuticals Inc., Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen, USP 500 mg

PURPOSE

Pain reliever/fever reducer

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

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

more than 4,000 mg of acetaminophen 24 hours.

with other drugs containing acetaminophen

3 or more alcoholic drinks everyday while using this product

Allergy alert: acetaminophen may cause severe skin reactions.Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you are allergic to acetaminophen or any other inactive ingredients in this product.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask 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.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Over dose warning: In case of overdose, get medical help or Contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

do not take more than directed (see overdose warning)

• adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last ; ; do not take more than 6 caplets in 24 hours, unless directed by a doctor ; ; do not use for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F). See USP Controlled Room Temparature

avoid high humidity

See end panel for lot number and expiration date

INACTIVE INGREDIENTS

hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

QUESTIONS OR COMMENTS ?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

+All trademarkes are property of their reapective owners.

This product is not affliated with the makers/owners of

Extra Strength Tylenol ® Caplets.

Distributed by:

Granules Pharmaceuticals INc.,

Chantilly, VA 20151

MADE IN INDIA

Rev.08/21

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70010-161
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
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white (White to off-White)	Score	no score
Shape	CAPSULE (Caplet shape)	Size	17mm
Flavor		Imprint Code	G551
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70010-161-01	1 in 1 CARTON	02/15/2022
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70010-161-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2022
3	NDC: 70010-161-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		02/15/2022

Labeler - Granules Pharmaceuticals Inc. (079825711)

Registrant - Granules India Limited (918609236)