DrugCite

APAP  - acetaminophen tablet 
Advance Pharmaceutical Inc.

ACETAMINOPHEN USP 500 mg

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever / Fever Reducer

Uses

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

Warnings

Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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.

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. 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 over dose warning) adults & children 12 years and over :
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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

Other Information

  • 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.

Inactive Ingredients

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

Questions or Comments

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70309c76-figure-01

70309c76-figure-02

70309c76-figure-03

NDC: 17714-014-01 – 100 COUNT

NDC: 17714-014-10 – 1000 COUNT


APAP 
acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 17714-014
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
POVIDONE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code AP;014
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 17714-014-01 100 TABLET In 1 BOTTLE None
2 17714-014-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 01/14/1990

Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
Name Address ID/FEI Operations
Advance Pharmaceutical Inc. 078301063 MANUFACTURE
Revised: 03/2013Advance Pharmaceutical Inc.