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Pain Relief

Medicine Shoppe International Inc

Medicine Shoppe International, Inc. 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. 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

Pain Relief Other information

  • store at 20º–25ºC (68º-77ºF)

Inactive ingredients

croscarmellose sodium, D&C[Enter image caption here] 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

Extra Strength Geltabs

Pain Relief

Non Aspirin

Acetaminophen

Pain Reliever/Fever Reducer

Compare to Extra Strength Tylenol® active ingredient

500 mg Each

Pain Relief
Pain Relief Carton

Pain Relief

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49614-188
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
1 100 in 1 BOTTLE
2 NDC:49614-188-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1994-11-20


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Be sure to consult your doctor before taking any medication!
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