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APAP

Contract Pharmacal Corp




FULL PRESCRIBING INFORMATION

Drug Facts

(in each caplet)
Acetaminophen 500 mg

Analgesic, Antipyretic

  • temporarily relieves minor aches and pains associated with
  • the common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
  • reduction of fever

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

Acetaminophen may cause liver damage.

  • if you are taking other acetaminophen products
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

ask a health professional before use.

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years of age and over take 2 tablets every  4 hour to 6 hours, not to exceed 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
children under 12 years of age Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and may cause liver damage.

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at room temperature, USP

Hypromellose, Mineral Oil, Polyethylene Glycol, Povidone, Pregelatinized Starch, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

Manufactured by:
CONTRACT PHARMACAL CORP.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.CPCHealth.com
Rev. 01/09

APAP

APAP

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10267-1190
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
LIGHT MINERAL OIL
polyethylene glycol 400
POVIDONE K30
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Shape
WHITE 17 mm OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10267-1190-6 50 in 1 BOTTLE
2 NDC:10267-1190-1 100 in 1 BOTTLE
3 NDC:10267-1190-5 500 in 1 BOTTLE
4 NDC:10267-1190-4 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2001-01-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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