Acetaminophen Rapid Release Extra Strength
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Western Family Foods Inc
NDC Code: 55312-046
Western Family Acetaminophen 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. The maximum daily dose of this product is 6 gelcaps (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 have ever had an allergic reaction to this product or any of its ingredients
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.
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 Liver warning)
|
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 |
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, pregelatinized starch, stearic acid, titanium dioxide
Principal Display Panel
See New Warnings & Directions
EXTRA STRENGTH
RAPID RELEASE
Acetaminophen
PAIN RELIEVER / FEVER REDUCER
COMPARE TO TYLENOL® RAPID RELEASE GELS active ingredient
500 mg each
Acetaminophen Carton Image 1
Acetaminophen Carton Image 2
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
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
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color RED (grey top) Score no score
Shape CAPSULE (tablet) Size 19mm
Flavor Imprint Code L046
Contains
Packaging
Item Code Package Description
1 NDC:55312-046-71 1 BOTTLE (BOTTLE) in 1 CARTON
1 50 TABLET, COATED (TABLET) in 1 BOTTLE
2 NDC:55312-046-78 1 BOTTLE (BOTTLE) in 1 CARTON
2 100 TABLET, COATED (TABLET) in 1 BOTTLE
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: 07/2012
Document Id: 2ffab2fc-683f-42d7-b346-4ff73ac02b07Set id: 42f82a09-2bf5-4902-bff3-99e48633fca1Version: 2Effective Time: 20120725
