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Medicine Shoppe International Inc

Medicine Shoppe International, Inc. Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

pain relief Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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 the user

  • has liver disease
  • is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
  • 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours

children

6-11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours

children under

6 years
do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

REGULAR STRENGTH TABLETS

See New Warnings Information

PAIN RELIEF

Non Aspirin

Acetaminophen

COMPARE TO TYLENOL® TABLETS active ingredient

Pain Reliever/Fever Reducer

325 mg Each

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

pain relief

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49614-118
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
povidone
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm 325MG;L403 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:49614-118-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1987-07-15


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