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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 caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

pain relief Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces fever

Warnings

Overdose warning: Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

  • with any other product containing acetaminophen

Stop use and ask a doctor if

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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

  • do not use more than directed (see overdose warning)
  • adults and children 12 years and over: take 2 caplets every 6 hours as needed
  • do not take more than 8 caplets 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 could cause serious health problems

pain relief Other information

  • store at room temperature (59º-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, starch, stearic acid *may contain one or more of these ingredients

Principal Display Panel

EXTRA STRENGTH CAPLETS

PAIN RELIEF

Non Aspirin - Acetaminophen

Pain Reliever/Fever Reducer

COMPARE TO EXTRA STRENGTH TYLENOL® active ingredient

500 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:49614-123
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
carnauba wax
CROSCARMELLOSE SODIUM
HYPROMELLOSES
POLYETHYLENE GLYCOLS
povidone
SODIUM METABISULFITE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm L484 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 50 in 1 BOTTLE
3 NDC:49614-123-90 500 in 1 BOTTLE

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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