PAIN RELIEVER EXTRA 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 500 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 you take

• more than 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.
• 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
  
• new symptoms 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 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 6 hours while symptoms last
  
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
  
• do not take for more than 10 days unless directed by a doctor
  

• children under 12 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: 55315-148-12

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

Extra Strength
PAIN RELIEVER

ACETAMINOPHEN 500 mg
Pain Reliever/Fever Reducer

100 TABLETS

Contains no aspirin

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 Extra Strength Tylenol®.

50844    ORG061714812

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

100% satisfaction
            guaranteed
Questions or comments: 1-855-331-FRED (3733)

Freds Pharmacy 44-148

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 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	12mm
Flavor		Imprint Code	44;148
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-148-12	1 in 1 CARTON	01/21/1993
1		100 in 1 BOTTLE, PLASTIC; 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	01/21/1993

Labeler - FRED'S, INC. (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(55315-148)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55315-148)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55315-148)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55315-148)