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Kroger Company

Kroger Co. Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

pain relief 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. The maximum daily dose of this product is 6 geltabs (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 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

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 for more than 10 days
  • fever gets worse or lasts for 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.

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 while symptoms last
  • do not take more than 6 geltabs in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor

pain relief Other information

  • store at 20º–25ºC (68º-77ºF)

Inactive ingredients

corn starch*,  croscarmellose sodium*, D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate*, stearic acid, titanium dioxide *May contain one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

Easy To Swallow Geltabs

COMPARE TO active ingredient of EXTRA STRENGTH TYLENOL®

See bottom panel

Acetaminophen

EXTRA STRENGTH

SEE NEW WARNINGS AND DIRECTIONS

Pain Relief

Pain Reliever/Fever Reducer

500 mg EACH

pain relief
Pain Relief Carton Image 1 Pain Relief Carton Image 2

pain relief

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-187
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
EDETATE DISODIUM
GELATIN
GLYCERIN
HYPROMELLOSES
POLYETHYLENE GLYCOLS
povidone
water
STEARIC ACID
titanium dioxide
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
RED 10 mm L187 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:30142-187-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1994-10-28


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