Your browser does not support JavaScript! EXTRA STRENGTH QPAP (ACETAMINOPHEN) TABLET, COATED [QUALITEST PHARMACEUTICALS]
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EXTRA STRENGTH QPAP (acetaminophen) tablet, coated
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

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

Warnings

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

  • more than 8 caplets 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 
  • new symptoms occur
  • redness or swelling is present

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 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 caplets every 4 to 6 hours while symptoms last
  • do not take more than 8 caplets 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 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

hypromellose, povidone, pregelatinized starch, stearic acid

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 8/09 R9
8273399  0029

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Extra Strength Q-Pap Acetaminophen 500 mg Caplets.
EXTRA STRENGTH QPAP 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0265
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (capsule-shaped) Size17mm
FlavorImprint Code 0029;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0265-211 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:0603-0265-321000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/01/1996
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville958430845MANUFACTURE

Revised: 5/2010
 
Qualitest Pharmaceuticals

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