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Acetaminophen by New World Imports, Inc

Medically reviewed on August 8, 2017

Dosage form: tablet
Ingredients: Acetaminophen 325mg
Labeler: New World Imports, Inc
NDC Code: 51824-010

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.

label

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn 
Stearic Acid 
Povidone 
Sodium starch glycolate type A potato 
Product Characteristics
Colorwhite (white ) Scoreno score
ShapeROUND (Round Circle) Size11mm
FlavorImprint CodeAZ;010
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-010-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/10/201008/01/2020
Labeler - New World Imports, Inc (075372276)

 
New World Imports, Inc

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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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