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Extra Strength QPAP by Qualitest Pharmaceuticals

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0268

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.

Q-PAP Extra Strength Acetaminophen Tablets

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily reduces fever and relieves minor aches and pains caused by:

  • Common cold
  • headache
  • toothache
  • muscular aches
  • Premenstrual and menstrual cramps

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • 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 nonprescription). 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 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 appear

These could be signs of a serious condition

If pregnant or breastfeeding,

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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). 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 tablets every 4 to 6 hours while symptoms last, not more than 8 tablets in 24 hours, do not take for more than 10 days unless directed by a doctor

children under 12 years

do not use adult Extra Strength 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 at room temperature 15° to 30°C (59° to 86°F)
  • you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811

Inactive ingredients

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

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

Made in the USA

For Qualitest Pharmaceuticals

Huntsville, AL 35811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH QPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0268
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
CARBOXYMETHYLCELLULOSE SODIUM 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Flat Face Bevel Edge) Size12mm
FlavorImprint Code0031;V
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0268-29100 TABLET in 1 BOTTLE, PLASTIC
2NDC:0603-0268-321000 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/02/201107/31/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical, Inc.078301063MANUFACTURE(0603-0268)

Revised: 02/2017
 
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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