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APAP

Contract Pharmacal Corp




FULL PRESCRIBING INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

(in each tablet)
Acetaminophen 325 mg

Analgesic
Antipyretic

  • temporarily relieves minor aches and pains due to
  • the common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • minor pain of arthritis
  • menstrual cramps
  • temporarily reduces fever

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adults take more than 12 tablets in 24 hours, which is the maximum daily amount
  • child take more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any other inactive ingredients in this products

liver disease

taking the blood thinning drug warfarin

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

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.CPCHealth.com
Rev. 05/10

Drug Facts (continued)

  • pain gets worse or lasts for more than 10 days in adults and children
  • pain gets worse or lasts for more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present.

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 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

  • Do not take more than directed (see overdose warning).
adults and children 12 years of age and over take 2 tablets every 4 to 6 hours; not to exceed 12 tablets in 24 hours
children 6-11 years of age take 1 tablets every 4 to 6 hours; not to exceed 5 tablets in 24 hours
children under 6 years of age 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

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at controlled room temperature, USP
  • side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Polyvinylpyrrolodone, Pregelatinized Starch, Sodium Starch Glycolate and Stearic Acid.

APAP

APAP

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10267-0220
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
POVIDONE K30
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm CPC;220 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10267-0220-1 100 in 1 BOTTLE
2 NDC:10267-0220-5 500 in 1 BOTTLE
3 NDC:10267-0220-4 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2001-05-29


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Be sure to consult your doctor before taking any medication!
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