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Manufacturer:Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Category:Over-the-counter (OTC) Marketed Drugs

Acetaminophen Tablet 500mg

ACETAMINOPHEN - acetaminophen tablet 
NCS HealthCare of KY, Inc dba Vangard Labs

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 500mg

Active ingredient(s)

Acetaminophen 500mg


Pain Reliever/Fever Reducer


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.


Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, or with other durgs containing acetaminophen, or 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.


ask a health professionsl before use.

Keep out of reach of children

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.


Do not take more than directed.

Adults and Children 12 years and over: Take 2 tablets every 4 to 6 hours while symptoms last. 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.


Adverse Drug Event call (800) 616-2471. Dist. By Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

Principal Display Panel

Acetaminophen Tablets 500mg

Acetaminophen Tablets 500mg

acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-4510(NDC:0904-1988)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code GPI;A5
# Item Code Package Description Multilevel Packaging
1 NDC:0615-4510-31 31 TABLET (31 TABLET) in 1 BLISTER PACK None
2 NDC:0615-4510-39 30 TABLET (30 TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 08/05/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL, REPACK

Revised: 08/2010 NCS HealthCare of KY, Inc dba Vangard Labs

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2018 by Dionisios Fentas || Terms of Use


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