Acetaminophen Tablets, 325mg (uncoated)

Label at a glance#

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)/Purpose

OTC - ACTIVE INGREDIENT SECTION

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

Uses 

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains associated with

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

Purpose

OTC - PURPOSE SECTION

Analgesic/Antipyretic

Warnings

WARNINGS SECTION

Alcohol warning:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

with any other products containing acetaminophen.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients corn starch, pregelatinized starch, stearic acid.

May contain povidone and sodium starch glycolates.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

• Acetaminophen
• STARCH, CORN

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

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openFDA label cross-check#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.