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.

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Acetaminophen Tablet 500mg

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain Reliever/Fever Reducer

Uses

for the temporary relief of minor aches and pains due to:

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.

If pregnant or breast-feeding, 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:

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

Inactive ingredients

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

Questions or comments?

(800) 616-2471

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR PHARMACEUTICALS

31778 Enterprise Drive. Livonia, MI 48150 USA

Rev. 02/12 M-95

Principal Display Panel

Acetaminophen Tabs 500mg bingo card label 

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-4510(NDC:0904-1988)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (round flat faced beveled edge) Size 12mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-4510-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 05/04/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/04/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-4510) , REPACK(0615-4510)

Revised: 1/2017
Document Id: 8586a1ae-87ad-47b2-bfec-1fabdbffd914
Set id: 5a42628d-c45d-4339-b1b8-c9b07b89cfae
Version: 11
Effective Time: 20170110
 
NCS HealthCare of KY, Inc dba Vangard Labs