PAIN RELIEVER REGULAR STRENGTH- acetaminophen tablet

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by FRED'S, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325 mg 

Purpose

Pain reliever/fever reducer 

Uses

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

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• 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

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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has

liver disease.

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
• redness or swelling is present
  
• pain gets worse or lasts more than 5 days in children under 12 years
• new symptoms occur
  
• fever gets worse or lasts more than 3 days

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 to 6 hours while symptoms last; ■ do not take more than 10 tablets in 24 hours; ■ do not take for more than 10 days unless directed by a doctor
• children 6-11 years: ■ take 1 tablet every 4 to 6 hours while symptoms last; ■ do not take more than 5 tablets in 24 hours; ■ do not take for more than 5 days unless directed by a doctor
• children under 6 years: ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391 

Principal Display Panel

fred's
Pharmacy

NDC: 55315-105-12

Compare to the active ingredient in:
Regular Strength Tylenol®*

Regular Strength

PAIN RELIEVER
Acetaminophen, 325 mg
Pain Reliever/Fever Reducer

100 TABLETS

Actual
Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Regular Strength Tylenol®.
50844      REV0417A10412

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction guaranteed

Freds Pharmacy 44-104

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  REGULAR STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-105
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-105-12	1 in 1 CARTON	07/13/1990
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/13/1990

Labeler - FRED'S, INC. (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55315-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(55315-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55315-105)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55315-105)