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

Extra Strength Pain Relief

Greenbrier International, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Assured 44-519

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

Uses

  • temporarily relieves minor aches and ains due to:
    • headache
    • backache
    • toothache
    • the common cold
    • minor pain of arthritis
    • muscular aches
    • premesntrual 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 every day while uding this product

Do not use

with any other drug containing acetaminophen (prescription or non-prescription). 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 of symptoms.

Directions

  • do not take more 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 unlesss directed by a doctor
  • children under 12 years of age: 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 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

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, simithicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

*COMPARE TO ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS

Extra Strength
Pain Relief
Acetaminophen
500 mg
Pain reliever / Fever reducer
contains no aspirin

12 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          REV0513B51902

Principal Display Panel
Assured 44-519

Extra Strength Pain Relief

Acetaminophen CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0519
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
ferric oxide red
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
DIMETHICONE
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 12 in 1 BOTTLE, PLASTIC
2 NDC:33992-0519-2 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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