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

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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. 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.

Pregnancy/Breastfeeding

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.

Directions

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

Storage

Store at room temperature.

Inactive ingredients

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

Questions

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 
acetaminophen   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0615-4510 (0904-1988)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code GPI;A5
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10615-4510-3131 TABLET In 1 BLISTER PACKNone
20615-4510-3930 TABLET In 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34308/05/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL, REPACK
Revised: 08/2010NCS HealthCare of KY, Inc dba Vangard Labs