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Name:Acetaminophenrapid Release Extra Strength
Manufacturer:Western Family Foods Inc
Category:Over-the-counter (OTC) Marketed Drugs


Western Family Foods, Inc. Acetaminophen Gelcaps Drug Facts

ACETAMINOPHEN RAPID RELEASE EXTRA STRENGTH - acetaminophen tablet, coated 
Western Family Foods Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Western Family Foods, Inc. Acetaminophen Gelcaps Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

  • more than 8 gelcaps 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.

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

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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. 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 use more than directed (see Liver warning)

adults and children 12

years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 8 gelcaps in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause liver damage

Other information

store at 20°-25°C (68°-77°F)

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, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Principal Display Panel

See New Warnings Information

Extra Strength

Rapid Release

Acetaminophen

Pain Reliever/Fever Reducer

Fast Relief

Compare to Tylenol® Rapid Release Gels active ingredient

500 mg each

Acetaminophen Gelcaps Carton

Acetaminophen Gelcaps Carton


ACETAMINOPHEN  RAPID RELEASE EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-046
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Product Characteristics
Color RED (grey top) Score no score
Shape CAPSULE (tablet) Size 19mm
Flavor Imprint Code L046
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55312-046-71 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 50 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55312-046-71)
2 NDC:55312-046-78 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 100 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55312-046-78)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/19/2009

Labeler - Western Family Foods Inc (192166072)

Revised: 06/2009 Western Family Foods Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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