simply right acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

simply right acetaminophen

Sam's West Inc

  • 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
Sam’s West, Inc. Extra Strength Acetaminophen Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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

    carnauba wax*, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain one or more of these ingredients

    Questions or comments?

    1-800-809-0469

    Principal Display Panel - package

    TWIN PACK

    extra strength

    acetaminophen

    500 mg caplets

    pain reliever/fever reducer

    Compare to Extra Strength Tylenol® active ingredient

    Contains no aspirin

    Easy to swallow

    For adults

    1200 caplets

    actual size

    Principal Display Panel – single label

    Pain reliever

    extra strength

    acetaminophen

    500 mg caplets

    pain reliever/fever reducer

    Compare to Extra Strength Tylenol® active ingredient

    Contains no aspirin

    Easy to swallow

    For adults

    actual size

    600 caplets

    simply right acetaminophen

    Acetaminophen TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:68196-553
    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
    STARCH, CORN
    HYPROMELLOSES
    POLYETHYLENE GLYCOLS
    POVIDONES
    STEARIC ACID
    CROSCARMELLOSE SODIUM

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 16 mm L484 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-553-61 600 in 1 BOTTLE
    2 NDC:68196-553-04 2 in 1 PACKAGE

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 2014-02-13


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    Be sure to consult your doctor before taking any medication!
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