EXTRA STRENGTH QPAP- acetaminophen tablet
Preferred Pharmaceuticals, Inc.

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

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH QPAP
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-9196(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, UNSPECIFIED FORM (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:68788-9196-2	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2011	09/16/2019
2	NDC:68788-9196-3	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2011	09/16/2019
3	NDC:68788-9196-4	45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2011	09/16/2019
4	NDC:68788-9196-5	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2011	09/16/2019
5	NDC:68788-9196-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/03/2011	09/16/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/03/2011	09/16/2019

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-9196)

Revised: 9/2019

Document Id: 172b48bd-a08b-495b-8ac5-6cf6bcaaea39

Set id: beb90934-9ec4-4bb4-90a4-29d17cacc4e8

Version: 6

Effective Time: 20190916

Preferred Pharmaceuticals, Inc.