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Acetaminophen by Chain Drug Consortium, LLC

Medically reviewed on March 31, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-655

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen Tablets, USP 325 mg

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

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-655
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN 
POVIDONE K30 
STEARIC ACID 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
POLYETHYLENE GLYCOLS 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG323
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-655-10100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/25/2016
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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