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Acetaminophen

McKesson Packaging Services Business Unit of McKesson Corporation

Acetaminophen Tablets, 325mg (uncoated)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each tablet)/Purpose

Acetaminophen 325mg....................Analgesic/Antipyretic

temporary relief of minor aches and pains associated with

  • •common cold
  • •headache
  • •toothache
  • •muscular aches
  • •backache
  • •arthritis
  • •menstrual cramps
  • •and reduction of fever

Purpose

Analgesic/Antipyretic

Warnings

Alcohol warning:

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

Do not use

with any other products containing acetaminophen.

Stop use and ask a doctor if

  • •symptoms do not improve
  • •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
  • •a rare sensitivity reaction occurs

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

Directions

Adults and children 12 years of age and older

  • •take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children 6-11 years of age

  • •Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.

Children under 6 years of age

  • •Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

  • •store at room temperature 59°-86°F (15°-30°C).

Inactive Ingredients corn starch, pregelatinized starch, stearic acid.

May contain povidone and sodium starch glycolates.

PRINCIPAL DISPLAY PANEL

Acetaminophen

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63739-440(NDC:62211-010)
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
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm AZ;010 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 NDC:63739-440-01 25 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2009-03-01


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