Extra Strength Non-Aspirin description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Non-Aspirin

CHAIN DRUG MARKETING ASSOCIATION INC

Quality Choice 44-519


FULL PRESCRIBING INFORMATION: CONTENTS*




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. 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

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 (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.

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

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

Questions or comments?

1-800-426-9391

QC
QUALITY
CHOICE®

NDC 63868-987-50

Compare to the active Ingredient In Extra Strength Tylenol® Rapid Release Gels†

Non-Aspirin
Pain Relief
Extra Strength
Acetaminophen,
500 mg
Pain Reliever | Fever Reducer

50 Gelcaps (500 mg EACH)

Rapid Release Gelcaps

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

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.
50844        REV0513B51915

©DISTRIBUTED BY QUALITY CHOICE
NOVI, MI 48376-0995

Extra Strength Non-Aspirin
Quality Choice 44-519

Extra Strength Non-Aspirin

Acetaminophen CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-987
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 (TYPE H)
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOLS
POVIDONES
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
1 100 in 1 BOTTLE, PLASTIC
2 50 in 1 BOTTLE, PLASTIC
3 NDC:63868-987-50 1 in 1 CARTON

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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