REGULAR STRENGTH QPAP- acetaminophen tablet

Regular Strength QPAP by

Drug Labeling and Warnings

Regular Strength QPAP by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325 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

• adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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 DOCTOR

Ask a doctor before use if the user has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults and children
• pain gets worse or lasts more than 5 days in children under 12 years
• 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.

PREGNANCY OR BREAST FEEDING

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. (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
  • do not take more than 12 tablets in 24 hours
• children 6 years to 11 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
• children under 6 years: do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

povidone, pregelatinized starch, stearic acid

Acetaminophen 325 mg. Tablet

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH QPAP 
acetaminophen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63629-1518(NDC: 0603-0263)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	0027;V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-1518-1	20 in 1 BOTTLE
2	NDC: 63629-1518-2	100 in 1 BOTTLE
3	NDC: 63629-1518-3	30 in 1 BOTTLE
4	NDC: 63629-1518-4	2 in 1 BOTTLE
5	NDC: 63629-1518-5	6 in 1 BOTTLE
6	NDC: 63629-1518-6	10 in 1 BOTTLE
7	NDC: 63629-1518-7	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/01/1996

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-1518) , RELABEL(63629-1518)