REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet

Regular Strength Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

• temporarily relieves minor aches and pains
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets
in 24 hours. Severe liver damage may occur if you take:

• more than 12 tablets (4,000 mg of acetaminophen)

in 24 hours

• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using

this product
Allergy alert: acetaminophen may cause severe skin
reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

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 symptom 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. In case of overdose, get
medical help or contact a Poison Control Center right away.
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
• adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
• children under 12 years: ask a doctor

Other Information

• store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

HOW SUPPLIED

Product: 71335-1281

NDC: 71335-1281-0 24 TABLET in a BOTTLE

NDC: 71335-1281-1 20 TABLET in a BOTTLE

NDC: 71335-1281-2 100 TABLET in a BOTTLE

NDC: 71335-1281-3 30 TABLET in a BOTTLE

NDC: 71335-1281-4 2 TABLET in a BOTTLE

NDC: 71335-1281-5 6 TABLET in a BOTTLE

NDC: 71335-1281-6 10 TABLET in a BOTTLE

NDC: 71335-1281-7 60 TABLET in a BOTTLE

NDC: 71335-1281-8 90 TABLET in a BOTTLE

NDC: 71335-1281-9 40 TABLET in a BOTTLE

Acetaminophen 325 mg. Tablet

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1281(NDC:57896-102)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	GC101
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-1281-0	24 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
2	NDC: 71335-1281-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
3	NDC: 71335-1281-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
4	NDC: 71335-1281-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
5	NDC: 71335-1281-4	2 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
6	NDC: 71335-1281-5	6 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
7	NDC: 71335-1281-6	10 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
8	NDC: 71335-1281-7	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
9	NDC: 71335-1281-8	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989
10	NDC: 71335-1281-9	40 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1989

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/01/1989

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-1281) , RELABEL(71335-1281)