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Acetaminophen by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on June 4, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-4554

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 Tablet doubles

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 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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
  • 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:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical help 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 (see overdose warning)

 

AGE  DOSE
 adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor.
  • do not use for more than 10 days unless directed by a doctor.
 children 6 years to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor.
 children under 6 yearsask a doctor

Other information
  • Store at room temperature

Inactive ingredients

Povidone, pregelantized starch, sodium starch glycolate, stearic acid

Questions or comments?

call (800) 616-2471

Principal Display Panel
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-4554(NDC:0904-1982)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K12 
STARCH, CORN 
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:0615-4554-6760 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 Labs050052943REPACK(0615-4554)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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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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