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

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Acetaminophen Extended Release

NCS HealthCare of KY, Inc dba Vangard Labs

Acetaminophen ER 650mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient (In each caplet)

Acetaminophen 650mg

Pain reliever/fever reducer

    •    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

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

    •    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

liver disease

taking the blood thinning drug warfarin

    •    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

These could be signs of a serious condition.

ask a health professional before use.

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.

    •    do not take more than directed (see overdose warning)

adults

•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 doctor

under 18 years of age

•ask a doctor

    •    store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).

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

1-800-719-9260

Gluten Free

Distributed by: MAJOR® PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48510 USA

M-05 REV. 09/12

Principal Display Panel

Acetaminophen Extended-Release Tablets 650mg

Acetaminophen Extended Release

Acetaminophen Extended Release

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-7590(NDC:0904-5769)
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
STARCH, CORN
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 NDC:0615-7590-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 2000-02-25


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