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Pain Reliever Regular Strength

Medically reviewed on November 2, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: FRED'S, INC.
NDC Code: 55315-105

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.

Freds 44-104

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 15º-30ºC (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

Freds
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

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 44-104

PAIN RELIEVER  REGULAR STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code44;104
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-105-121 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/13/1990
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-105)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(55315-105)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-105)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-105)

 
FRED'S, INC.

← See all Pain Reliever Regular Strength brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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