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

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, 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

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.

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
acetaminophen tablet

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

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63739-440-01	25 in 1 BOX, UNIT-DOSE	04/30/2009	07/31/2021
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/01/2009	07/31/2021

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

Revised: 7/2021

Document Id: c741047f-2c14-1220-e053-2a95a90aecb4

Set id: a651c724-3f52-44a9-a690-69710214927d

Version: 4

Effective Time: 20210716

McKesson Packaging Services Business Unit of McKesson Corporation