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Acetaminophen Extra Strength by New World Imports, Inc

Medically reviewed on August 8, 2017

Dosage form: tablet
Ingredients: Acetaminophen 500mg
Labeler: New World Imports, Inc
NDC Code: 51824-011

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

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, Pregelatinized Starch, Stearic Acid. May also contain prvidone and sodium starch glycolate

Label

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn 
Stearic Acid 
Povidone 
Sodium starch glycolate Type A potato 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size12mm
FlavorImprint CodeAZ;011
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-011-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/14/201008/01/2020
Labeler - New World Imports, Inc (075372276)

 
New World Imports, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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