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Name:Acetaminophenextra Strength
Manufacturer:New World Imports, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ACETAMINOPHEN EXTRA STRENGTH - acetaminophen tablet, coated 
New World Imports, 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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Drug Facts

Acteminophen 500 mg

Pain reliever / Fever reducer

In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, menstrual cramps, and reduction in fever.

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

-more than 8 caplets 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:

-Symptoms do not improve

-Pain gets worse or lasts for more than 10 days

-Fever gets worse or lasts for more than 3 days

-New symptoms occur

-Redness or swelling is present

-A rare sensitivity reaction occurs

-You may report side effects to 1-888-952-0050

If pregnant of breast-feeding, ask a health professional before use.

Do not exceed recommended dosage.

Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours as needed.  Do not take more than 8 caplets in 24 hours.

Children under 12 years of age: Do not use this extra strength product.  This will provide more than the recommended dose (overdose) and could cause serious health problems.

Corn Starch, Hydroxypropyl methylcellulose, Pregelatinized Starch, Propylene Glycol, Stearic Acid, Titanium Dioxide.  May contain povidone and sodium starch glycolates.

Image of Bottle


ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-012
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
Starch, Corn  
Hydroxypropyl Cellulose  
Propylene Glycol  
Stearic Acid  
Titanium Dioxide  
Povidone  
Sodium Starch Glycolate Type A Potato  
Product Characteristics
Color white (White) Score no score
Shape OVAL (Oval) Size 18mm
Flavor Imprint Code AZ;012
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51824-012-01 100 TABLET, COATED ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 09/14/2010

Labeler - New World Imports, Inc (075372276)

Revised: 09/2010 New World Imports, Inc



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


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