Your browser does not support JavaScript! EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [FRED'S, INC.]
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RxNorm Names

EXTRA STRENGTH PAIN RELIEVER (acetaminophen) capsule, gelatin coated
[FRED'S, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each gelcap)

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. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 ever 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.

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.

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 (1-800-222-1222) 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 mroe than directed
    (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 to 6 hours while symptoms last
    • do not take more than 8 gelcaps in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Product Packaging

FRED'S®

Extra Strength
Pain Reliever
Acetaminophen
Pain Reliever/Fever Reducer
Rapid Release Gel Caps

50 Gelcaps, 500 mg each

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

*This product is not manufactured or distributed McNeil Consumer Healthcare, owner of the registered trademark Extra Strength® Rapid Release Gels.
50844        REV0213D51915

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

Fred's 44-519

Fred's 44-519

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-519-571 in 1 CARTON
1125 in 1 BOTTLE, PLASTIC
2NDC:55315-519-121 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
3NDC:55315-519-151 in 1 CARTON
350 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-519)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-519)

Revised: 3/2013
 
FRED'S, INC.

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