Acetaminophen Tablet 500mg

ACETAMINOPHEN - acetaminophen tablet 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Active ingredient(s)

Acetaminophen 500mg

Purpose

Pain Reliever/Fever Reducer

Use(s)

for the temporary relief of 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 tablets in 24 hours, which is the maximum daily amount, or with other drugs containing acetaminophen, or 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.

Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.

Directions

Do not take more than directed.

Adults and Children 12 years and over: Take 2 tablets every 4 to 6 hours while symptoms last.

Do not take more than 8 tablets in 24 hours.

Do not take for more than 10 days unless directed by a doctor.

Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age: this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

Store at room temperature.

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions

Adverse Drug Event call (800) 616-2471.

Dist. By Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

Compare to the active ingredient in Extra Strength Tylenol® Tablets*

*This product is not manufactured or distributed by McNeil Consumer Products Co.,

owner of the registered trademark Tylenol®.

Rev 09/10

 

EXTRA STRENGTH

Mapap

ACETAMINOPHEN TABLETS

500 mg. EACH

See New Warnings Information

ASPIRIN FREE

EXTRA STRENGTH

PAIN RELIEVER

Cardinal Health

Zanesville, OH 43701

OI84120311

Principal Display Panel

Mapap Extra Strength

500 mg Tablets

(acetaminophen)

Blister

Principal Display Panel

Mapap Extra Strength

500 mg Tablets

Acetaminophen

QTY 30

Carton

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0746(NDC:0904-1988)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-0746-96 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
15 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (55154-0746-9)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/31/2011

Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 05/2011 Cardinal Health