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ACETAMINOPHEN by Cispharma, Inc

Medically reviewed on April 5, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cispharma, Inc
NDC Code: 52204-115

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 CAPLETS, 500 mg

Drug Facts

Active ingredient (in each caplet)

Acetaminophen .....................500 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 can cause serious health problems, including liver damage. In case of overdose, get medical help or contact poison control center right away. 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 as needed.
  • do not take more than 8 caplets in 24 hours
  • do not use more than 10 days unless directed by a doctor

children under 12 years

  • do not use this adult product in children under 12 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 the box is opened

Inactive Ingredients

Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®

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:52204-115
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSE 2910 (5 MPA.S) 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
POVIDONE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint CodeC;15
Contains    
Packaging
#Item CodePackage Description
1NDC:52204-115-9926549 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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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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