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

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Acetaminophen

AAA Pharmaceutical, Inc.

Acetaminophen Caplets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Acetaminophen 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 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

adults and children 12 years and over
  • 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
children under 12 years
  • ask a doctor

Acetaminophen Other information

  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton

RESTORE u

NDC 57344-004-04

COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL®
EXTRA STRENGTH

EXTRA
STRENGTH
CONTAINS NO ASPIRIN

Pain Relief

Pain Reliever, Fever Reducer

Contains Acetaminophen

100 CAPLETS - 500 mg each

Acetaminophen

Acetaminophen

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-004
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
HYPROMELLOSES
Mineral Oil
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm M2A4;57344 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 50 in 1 BOTTLE, PLASTIC
3 NDC:57344-004-03 100 in 1 BOTTLE, PLASTIC
4 100 in 1 BOTTLE, PLASTIC
5 250 in 1 BOTTLE, PLASTIC
6 NDC:57344-004-06 500 in 1 BOTTLE, PLASTIC
7 NDC:57344-004-07 1000 in 1 BOTTLE, PLASTIC
8 NDC:57344-004-08 150 in 1 BOTTLE, PLASTIC
9 100 in 1 BOTTLE, PLASTIC
10 NDC:57344-004-15 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-12-13


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