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ACETAMINOPHEN by Cispharma, Inc

Medically reviewed on March 28, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cispharma, Inc
NDC Code: 52204-113

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, 325mg

Drug Facts

Active ingredient (in each tablet)

Acetaminophen .............................. 325 mg

Pain Reliever/ Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • the common cold
  • backache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Warnings

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use with any other drug containing acetaminophen

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Indicated for pain relief.

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

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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 12 tablets in 24 hours
  • do not use more than 10 days unless directed by a doctor

children 6 years to 11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours

children under 6 years

  • do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information
  • store between 20°- 25°C (68°- 77°F)
  • do not use if carton is opened

Inactive Ingredients

povidone, pregelatinized starch, stearic acid

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52204-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColorWHITE (White) Score2 pieces
ShapeROUND (round) Size10mm
FlavorImprint CodeMLX;123
Contains    
Packaging
#Item CodePackage Description
1NDC:52204-113-9943956 TABLET (TABLET) in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/28/2011
Labeler - Cispharma, Inc (833171445)
Registrant - Cispharma, Inc (833171445)
Establishment
NameAddressID/FEIOperations
Cispharma, Inc833171445manufacture

 
Cispharma, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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