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(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:

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 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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K12 (UNII: 333AG72FWJ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-4510-31 31 in 1 BLISTER PACK
2 NDC:0615-4510-39 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 10/04/2012
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: 11/2012
Document Id: 765bce7c-41b2-4656-bdb2-74da80267506
Set id: 5a42628d-c45d-4339-b1b8-c9b07b89cfae
Version: 5
Effective Time: 20121106
 
NCS HealthCare of KY, Inc dba Vangard Labs