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APAP

Advance Pharmaceutical Inc.
Advance Pharmaceutical Inc.

ACETAMINOPHEN USP 500 mg




FULL PRESCRIBING INFORMATION

(in each tablet)

Acetaminophen 500 mg

Pain Reliever / Fever Reducer

temporarily relieves minor aches and pains due to

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

do not use

  • with any other drug containing acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • these could be signs of a serious condition.

If pregnant or breast-feeding, 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 a 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.

  • Do not take more than directed (see over dose warning) adults & children 12 years and over :
  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years : ask a doctor
  • store at 15-30 °C (59-86 °F)

For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

APAP

APAP

APAP

NDC: 17714-013-01 – 100 COUNT

NDC: 17714-013-10 – 1000 COUNT

APAP

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17714-013
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
povidone
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm AP;013 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17714-013-01 100 in 1 BOTTLE
2 NDC:17714-013-10 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1989-02-05


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