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Acetaminophen by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on April 21, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-0591

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 Tablets 325mg

Active ingredient (in each tablet)

Acetaminophen 325mg

Purposes

Pain reliever/fever reducer

Uses

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

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. 

• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if the user

has liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• Pain gets worse or lasts more than 10 days in adults and children

• Pain gets worse or lasts more than 5 days in children under 12 years

• 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.

If Pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In 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.

Directions

Do not take more than directed

AGEDOSE
Adults and children 12 years and over
  • Take 2 tablets every 4 to 6 hours while symptoms last
  • Do not take more than 12 tablets in 24 hours
Children 6 to 11 years
  • Take 1 tablet every 4 to 6 hours while symptoms last
  • Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information
  • Do no use if imprinted Safety Seal under cap is broken or missing.
  • Store at room temperature.

Inactive ingredients

Povidone, Pregelantized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

Adverse Drug Event call (800) 616-2471

Dist. By MAJOR PHARMACEUTICALS,

31778 Enterprise Drive,

Livonia, MI 48150 USA

Rev. 09/10  M-95

Principal Display Panel
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0591(NDC:0904-1982)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K12 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint CodeGPI;A325
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0591-3930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/21/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-0591), REPACK(0615-0591)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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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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