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Name:Acetaminophen
Manufacturer:Mckesson Packaging Services Business Unit Of Mckesson Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen Tablets, 325mg (uncoated)

ACETAMINOPHEN - acetaminophen tablet 
McKesson Packaging Services Business Unit of McKesson Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Acetaminophen Tablets, 325mg (uncoated)

Active Ingredient (in each tablet)/Purpose

Acetaminophen 325mg....................Analgesic/Antipyretic

Uses 

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • and reduction of fever

Warnings

Alcohol warning:

If you consume 3 or more alcoholic drinks every day, ask
your doctor whether you should take acetaminophen or other pain relievers/fever
reducers. Acetaminophen may cause liver damage.

Do not use

with any other products containing acetaminophen.

Stop use and ask a doctor if

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

Directions

Adults and children 12 years of age and older

  • take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children 6-11 years of age

  • Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.

Children under 6 years of age

  • Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

  • store at room temperature 59°-86°F (15°-30°C).

Inactive Ingredients corn starch, pregelatinized starch, stearic acid.

May contain povidone and sodium starch glycolates.

PRINCIPAL DISPLAY PANEL

Acetaminophen 325mg UD750 Label

SKY

NDC 63739-440-01

ACETAMINOPHEN
TABLETS, (uncoated)

Analgesic/Antipyretic

325 mg

UD 750 Tablets (25x30)

Keep out of reach of children.

Mfg. By: A & Z Pharmaceuticals Inc.
Hauppauge, NY 11788

Dist. By: McKesson Packaging
Concord, NC 28027

PRINCIPAL DISPLAY PANEL

Acetaminophen 325mg PC750 Label

SKY

NDC 63739-440-03

ACETAMINOPHEN
TABLETS, (uncoated)

Analgesic/Antipyretic

325 mg

PC 750 Tablets (25x30)

Keep out of reach of children.

Mfg. By: A & Z Pharmaceuticals Inc.
Hauppauge, NY 11788

Dist. By: McKesson Packaging
Concord, NC 28027


ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-440(NDC:62211-010)
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 10mm
Flavor Imprint Code AZ;010
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-440-01 25 BLISTER PACK ( BLISTER PACK) in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 30 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-440-01)
2 NDC:63739-440-03 25 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK
2 30 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BOX (63739-440-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 04/28/2009

Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
A & Z Pharmaceutical, Inc 926820705 MANUFACTURE
Establishment
Name Address ID/FEI Operations
McKesson Packaging Services Business Unit of McKesson Corporation 140529962 REPACK

Revised: 08/2009 McKesson Packaging Services Business Unit of McKesson Corporation



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


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