arthritis pain relief description, usages, side effects, indications, overdosage, supplying and lots more!

arthritis pain relief

Publix Super Markets 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
Publix Super Markets, Inc. Arthritis Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • •more than 6 caplets in 24 hours, which is the maximum daily amount
  • •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 are allergic to acetaminophen or any of the inactive ingredients in this product

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.

Overdose warning: 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 overdose warning)
take 2 caplets every 8 hours with water
  • swallow whole – do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctorask a doctor

    adults

    under 18 years of age

    Other information

    • •store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
    • •see end panel for lot number and expiration date

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

    Principal Display Panel

    TEMPORARY, MINOR

    arthritispainrelief

    ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650mg

    PAIN RELIEVER - FEVER REDUCER

    for the temporary relief of minor arthritis pain

    ACTUAL SIZE

    650mg EACH

    *Capsule-Shaped Tablets

    Compare to the Active Ingredient in Tylenol® Arthritis Pain

    arthritis pain relief

    Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:56062-544
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 650 mg

    Inactive Ingredients

    Ingredient Name Strength
    carnauba wax
    SILICON DIOXIDE
    CROSCARMELLOSE SODIUM
    HYPROMELLOSES
    MAGNESIUM STEARATE
    maltodextrin
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    polysorbate 80
    POVIDONES
    STEARIC ACID
    titanium dioxide

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 19 mm L544 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 24 in 1 BOTTLE
    2 100 in 1 BOTTLE
    3 NDC:56062-544-78 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075077 2007-11-26


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