Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

Acetaminophen

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Acetaminophen Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • •adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • •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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

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)
take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctortake 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctorask a doctor

    adults and children 12 years and over

    children 6-11 years

    children under 6 years

     

    Inactive ingredients

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

    Questions or comments?

    1-800-632-6900

    Principal Display Panel

    COMPARE TO the active ingredient of REGULAR STRENGTH TYLENOL® TABLETS

    See side panel

    Acetaminophen

    Pain Reliever/Fever Reducer

    REGULAR STRENGTH

    100 TABLETS

    325 mg EACH

    actual size

    Acetaminophen

    Acetaminophen TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:30142-403
    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
    POVIDONES
    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:30142-403-78 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 2014-05-12


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    Be sure to consult your doctor before taking any medication!
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