Extra Strength Pain Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Pain Relief

Dolgencorp, LLC

Rexall 44-519




FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg

Pain reliever/fever reducer

  • 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

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

  • more than 8 gelcaps in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever day while using this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • liver disease
  • taking the blood thinning drug warfarin
  • 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.

ask a health professional before use.

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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

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

Rexall®

Since 1903

EXTRA STRENGTH

Pain Relief

Acetaminophen 500 mg

SEE NEW WARNINGS INFORMATION

•Pain Reliever

•Fever reducer

•Fast release

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

50844      REV0709A51908

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSIONS RIDGE

GOODLETTSVILLE, TN 37072 USA

Extra Strength Pain Relief

Extra Strength Pain Relief

Acetaminophen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-812
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
hydroxypropyl cellulose
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOLS
povidone
propylene glycol
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 19 mm 44;519 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 NDC:55910-812-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-05-10


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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