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Name:Acetaminophen
Manufacturer:Cispharma, Inc
Category:Over-the-counter (OTC) Marketed Drugs


ACETAMINOPHEN CAPLETS, 500 mg

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 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 CAPLETS, 500 MG, Bulk

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-115
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
HYPROMELLOSE 2910 (5 MPA.S)  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
POVIDONE  
STARCH, PREGELATINIZED CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE (White) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code C;15
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52204-115-99 26549 TABLET ( TABLET) in 1 DRUM None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/28/2011

Labeler - Cispharma, Inc (833171445)
Registrant - Cispharma, Inc (833171445)
Establishment
Name Address ID/FEI Operations
Cispharma, Inc 833171445 manufacture

Revised: 04/2011 Cispharma, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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