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 44-531


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (n each tablet)

Acetaminophen 500 mg 

Purpose

Pain reliever/fever reducer 

Extra Strength Pain Relief 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 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every 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 right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms. 

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 8 tablets 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

Extra Strength Pain Relief Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient 

Principal display panel

Since 1903

Rexall®

PAIN RELIEVER/FEVER REDUCER

EXTRA STRENGTH

Pain Relief EZ Tabs

Acetaminophen 500 mg 

Easy Swallow Tablets (Sweet Coating)

SEE NEW WARNINGS INFORMATION

24 Coated Tablets

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

50844            REV1010A53108

Visit us at: Rexall.com

or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETSVILLE, TN 37072 USA

Extra Strength Pain Relief
531-08

Extra Strength Pain Relief

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-531
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
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C RED NO. 40
STARCH, CORN
talc
titanium dioxide
POLYVINYL ALCOHOL

Product Characteristics

Color Size Imprint Code Shape
RED 11 mm 44;531 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:55910-531-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-12-11


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