Acetaminophen by McKesson Packaging Services Business Unit of McKesson Corporation ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by McKesson Packaging Services Business Unit of McKesson Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Purpose

Analgesic/Antipyretic

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other Information

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

INACTIVE INGREDIENT

Inactive Ingredients corn starch, pregelatinized starch, stearic acid.

May contain povidone and sodium starch glycolates.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-440(NDC: 62211-010)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ;010
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63739-440-01	25 in 1 BOX, UNIT-DOSE
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/01/2009

Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)

Establishment
Name	Address	ID/FEI	Business Operations
McKesson Packaging Services Business Unit of McKesson Corporation		140529962	REPACK(63739-440)