EXTRA STRENGTH QPAP- acetaminophen tablet
Qualitest Pharmaceuticals

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.

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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

Image of the Q-PAP Extra Strength Tablets container label

EXTRA STRENGTH QPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0603-0268
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND (Flat Face Bevel Edge)	Size	12mm
Flavor		Imprint Code	0031;V
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0603-0268-29	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2011	07/31/2018
2	NDC:0603-0268-32	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2011	07/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	06/02/2011	07/31/2018

Labeler - Qualitest Pharmaceuticals (011103059)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical, Inc.		078301063	MANUFACTURE(0603-0268)

Revised: 2/2017

Document Id: 02e28975-0a1e-49fb-9d67-1cb229f7d4ce

Set id: 705c1883-a2e2-4682-a97b-d7febc1b3530

Version: 4

Effective Time: 20170214

Qualitest Pharmaceuticals