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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63739-440(NDC:62211-010)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code AZ;010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-440-0125 in 1 BOX, UNIT-DOSE
130 in 1 BLISTER PACK
2NDC:63739-440-0325 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other04/28/2009
Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)
Establishment
NameAddressID/FEIBusiness Operations
A & Z Pharmaceutical, Inc926820705MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
McKesson Packaging Services Business Unit of McKesson Corporation140529962REPACK

Revised: 8/2009
Document Id: a651c724-3f52-44a9-a690-69710214927d
Set id: a651c724-3f52-44a9-a690-69710214927d
Version: 1
Effective Time: 20090803
 
McKesson Packaging Services Business Unit of McKesson Corporation