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

Drug Facts

ACETAMINOPHEN  - acetaminophen tablet 
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.


Drug Facts

Acetaminophen 325mg

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 problems.

Temporary relief of minor aches and pains associated with:

common cold, headache, toothache, muscular aches, backache, arthritis, menstrual cramps, and reduction of fever

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

Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount

Child takes more than 5 doses in 24 hours

Taken with other drugs containing acetaminophen

Adult has 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 user has: liver disease

Ask a doctor or pharmacist before use if:the user is taking the blood thinnig 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 or breast-feeding,ask a health professional before use. 

Do not exceed recommended daily dosage.

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

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.  Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not sue this regular strength product.  This will provide more than the recommended dose (overdose) and could cause serious health problems.

Corn starch, pregelatinized starch, stearic acid.  May contain povidone and sodium starch glycolates.

Image of bottle label

acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-010
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn  
Stearic Acid  
Sodium starch glycolate type A potato  
Product Characteristics
Color white (white ) Score no score
Shape ROUND (Round Circle) Size 11mm
Flavor Imprint Code AZ;010
# Item Code Package Description Multilevel Packaging
1 NDC:51824-010-10 1000 TABLET ( 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

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2018 by Dionisios Fentas || Terms of Use


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