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Acetaminophen by Cardinal Health

Medically reviewed on October 6, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Cardinal Health
NDC Code: 55154-0746

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.

Acetaminophen Tablet 500mg
Mapap Tablets Extra Strength

Active ingredient

Drug Facts

Acetaminophen 500mg (in each tablet)

Purposes

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

See New Warnings Information.

This unit dose package is not child resistant and is intended for institutional use only. Keep out of reach of children.

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Liver Warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (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.

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

If pregnant or breast-feeding, 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 (see overdose warning)

Adults and children 12 years and over:

-take 2 tablets every 6 hours while symptoms last.

-do not take more than 6 tablets in 24 hours unless directed by a doctor

-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

Questions or comments? To Report Adverse Drug Event call (800) 616-2471.

Distributed by:

Major® Pharmaceuticals

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Repackaged by Cardinal Health

Zanesville, OH 43701

L4387353-10917

L4387353-20917

Principal Display Panel

Mapap Tablets

Extra Strength Acetaminophen

500 mg Tablets

10 Tablets

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, UNSPECIFIED 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0746-010 BLISTER PACK in 1 BAG
11 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/31/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-0746)

 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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