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
Kroger Co. Acetaminophen Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each gelcap)

Acetaminophen 500 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 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

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

  • •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

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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    Other information

    • •store at 20°-25°C (68°-77°F)

    Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

    Questions or comments?

    1-800-632-6900

    Principal Display Panel

    COMPARE TO the active ingredient of TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS

    See side panel

    FOR ADULTS

    Acetaminophen

    Pain Reliever / Fever Reducer

    EXTRA STRENGTH

    Rapid Release

    actual size

    24 GELCAPS

    500 mg EACH

    acetaminophen

    Acetaminophen TABLET, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:30142-100
    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
    SILICON DIOXIDE
    CROSCARMELLOSE SODIUM
    D&C RED NO. 33
    FD&C BLUE NO. 1
    FD&C RED NO. 40
    FD&C YELLOW NO. 6
    GELATIN
    HYDROXYPROPYL CELLULOSE (TYPE H)
    HYPROMELLOSES
    POVIDONES
    STEARIC ACID
    titanium dioxide
    POLYETHYLENE GLYCOLS

    Product Characteristics

    Color Size Imprint Code Shape
    RED (grey top) 19 mm L046 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 24 in 1 BOTTLE
    2 50 in 1 BOTTLE
    3 100 in 1 BOTTLE
    4 NDC:30142-100-78 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 2014-04-01


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