ACETAMINOPHEN- acetaminophen tablet 
Cispharma, Inc

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.

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ACETAMINOPHEN TABLETS, 500 mg

Drug Facts

Active ingredient (in each tablet)

Acetaminophen .............................. 500 mg

Pain Reliever/ Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

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
  • if needed, tablets may be crushed and should be taken immediately. Take the entire dose for best results. Crushing the tablets will result in bitter taste.
  • do not take more than 8 tablets 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

Inactive Ingredients

povidone, pregelatinized starch, stearic acid

*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 TABLETS, 500 mg, Bulk
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52204-114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColorWHITE (White) Score2 pieces
ShapeROUND (round) Size12mm
FlavorImprint Code MLX;152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52204-114-9935587 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/FEIBusiness Operations
Cispharma, Inc833171445manufacture

Revised: 3/2011
Document Id: d456e868-688a-4f9b-a7df-7c7087ab37ee
Set id: be410a33-7723-42da-aca0-b5aeb303aa3f
Version: 2
Effective Time: 20110328
 
Cispharma, Inc