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

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Acetaminophen Rapid Release

AAA Pharmaceutical, Inc.

Acetaminophen Rapid Release Gelcaps


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Acetaminophen Rapid Release 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. 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 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
children under 12 years
  • ask a doctor

Acetaminophen Rapid Release Other information

  • store between 20-25ºC (68-77ºF)
  • retain carton for complete product information

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, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

RESTOREu

NDC 57344-170-03

COMPARE TO THE ACTIVE
INGREDIENT IN TYLENOL®
EXTRA STRENGTH
RAPID RELEASE GELS

EXTRA
STRENGTH

CONTAINS NO ASPIRIN

RAPID
RELEASE

Pain Relief
For
Adults

Pain Reliever, Fever Reducer
Contains Acetaminophen

100 RAPID RELEASE GELCAPS - 500 mg each

Acetaminophen Rapid Release

Acetaminophen Rapid Release

Acetaminophen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-170
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
FERROSOFERRIC OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOLS
POVIDONES
STARCH, CORN
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GRAY (red and light blue ends) 19 mm G1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 50 in 1 BOTTLE, PLASTIC
3 100 in 1 BOTTLE, PLASTIC
4 NDC:57344-170-04 150 in 1 BOTTLE, PLASTIC
5 225 in 1 BOTTLE, PLASTIC
6 NDC:57344-170-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2014-03-26


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Be sure to consult your doctor before taking any medication!
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