Acetaminophen by Chain Drug Consortium, LLC ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each tablet)

Acetaminophen, USP 325 mg

Purpose

Pain Reliever/ Fever reducer

Uses

• temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

■ adult takes more than 4,000 mg of acetaminophen in 24 hours

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 3 or more alcoholic drinks every day while using this product

Do not use

■ with any other drug 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

the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days in adults

■ pain gets worse or lasts more than 5 days in children under 12 years

■ 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

Overdose warning

In case of overdose, get medical help or contact a 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 tablets every 4 to 6 hours while symptoms last

■ do not take more than 10 tablets in 24 hours

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

children 6-11 years

■ take 1 tablet every 4 to 6 hours while symptoms last

■ do not take more than 5 tablets in 24 hours

■ do not take more than 5 days unless directed by a doctor

children under 6 years

ask a doctor

Other information

■ store between 20-25°C (68-77°F).

■ do not use if carton is opened or neck wrap or foil inner seal imprinted is broken or missing

Inactive ingredients

hydroxy propyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, purified water, sodium starch glycolate, stearic acid

Questions or comments?

call 1-844-724-7347 Mon-Fri 9:00 AM to 4:30 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-655
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G323
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-655-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/25/2016

Labeler - Chain Drug Consortium, LLC (101668460)