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leader pain reliever

Cardinal Health

Cardinal Health Pain Reliever Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

leader pain reliever Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • 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 geltabs 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

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 more than directed (see Liver warning)
adults and children 12 years and over
  • take 2 geltabs every 6 hours as needed
  • do not take more than 8 geltabs in 24 hours
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) and may cause liver damage

leader pain reliever Other information

  • store at 20º–25ºC (68º-77ºF)

Inactive ingredients

croscarmellose sodium, D&C yellow no. 10, edetate disodium, edible ink, FD&C red no. 40, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Compare to Extra Strength Tylenol® active ingredient

Extra Strength

Pain Reliever

Acetaminophen

Contains no aspirin

Pain Reliever/Fever Reducer

Geltabs

500 mg each

Actual Size

leader pain reliever
Pain Reliever Carton

leader pain reliever

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-187
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 YELLOW NO. 10
EDETATE DISODIUM
FD&C RED NO. 40
GELATIN
GLYCERIN
HYPROMELLOSES
polyethylene glycol
povidone
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 10 mm L187 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:37205-187-71 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1996-07-09


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