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


Acetaminophen Tablets

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 Tablets

Active ingredient(s)

Acetaminophen 325mg

Purpose

Pain Reliever/fever reducer

Use(s)

for the temporary relief of minor aches and pains due to headaches, muscular aches, backaches, 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 adult takes more than 12 tablets in 24 hours, which is the maximum daily amount, child takes more than 5 doses in 24 hours, taken with other drugs containing acetaminophen, adult has 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 in adults and children. Pain gets worse or lasts more than 5 days in children under 12 years. 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 professional before use.

Keep out of reach of children

Keep out of reach of children

Overdose warning: Taking more than the recommeded dose (overdose) may cause lover damage. In 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 whild symptoms last.  Do not take more than 12 tablets in 24 hours.

Children 6-11 years:  Take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablet in 24 hours.

Children under 6 years:  Do not use adult Regular Strength products in children under 6 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 Glycolate, 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 325mg

Two Tablets/Blister

Acetaminophen Tablets 325mg    Two Tablets / Blister

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-4554(NDC:0904-1982)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 4mm
Flavor Imprint Code GPI;A325
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-4554-67 60 TABLET (60 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 08/04/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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