Your browser does not support JavaScript! ACETAMINOPHEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]
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RxNorm Names

ACETAMINOPHEN tablet
[NCS HealthCare of KY, Inc dba Vangard Labs]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient(s)

Acetaminophen 500mg

Purpose

Pain Reliever/Fever Reducer

Use(s)

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.

The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours.  Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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. If you are allergic to acetaminophen or any of the inactive ingredients in this product.

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

Pain gets worse or lasts more than 10 days, 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.

Pregnancy/Breastfeeding

ask a health professionsl before use.

Keep out of reach of children

Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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 the directed (see overdose warning)

Adults and children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours unless directed by a doctor
  • Do not take for more than 10 days unless directed by a doctor

Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

Do not use if imprinted safety seal under cap is broken or missing.

Store at room temperature

Inactive ingredients

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

Questions

To Report Adverse Drug Event call (800) 616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive. Livonia, MI 48150

Principal Display Panel

Acetaminophen Tablets 500mg

Acetaminophen Tablets 500mg

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0615-4510(NDC:0904-1988)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K12 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
12-HYDROXYSTEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0615-4510-3131 in 1 BLISTER PACK
2NDC:0615-4510-3930 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34310/04/2012
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-4510), REPACK(0615-4510)

Revised: 11/2012
 
NCS HealthCare of KY, Inc dba Vangard Labs

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