ACETAMINOPHEN TABLETS, 325mg

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen .............................. 325 mg

OTC - PURPOSE SECTION

Pain Reliever/ Fever Reducer

Uses

OTC - WHEN USING SECTION

Temporarily relieves minor aches and pains due to:

• headache
• the common cold
• backache
• muscular aches
• minor pain of arthritis
• toothache
• premenstrual and menstrual cramps

temporarily reduces fever

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use with any other drug containing acetaminophen

OTC - STOP USE SECTION

Stop use and ask a doctor if

• 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

These could be signs of a serious condition.

INDICATIONS & USAGE SECTION

Indicated for pain relief.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions: do not take more than directed (see overdose warning)

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours do not use more than 10 days unless directed by a doctor
children 6 years to 11 years	take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours
children under 6 years	do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

STORAGE AND HANDLING SECTION

• store between 20°- 25°C (68°- 77°F)
• do not use if carton is opened

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, stearic acid

SPL UNCLASSIFIED SECTION

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

• ACETAMINOPHEN
• POVIDONE
• STARCH, PREGELATINIZED CORN
• STEARIC ACID

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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.

Inactive ingredient links page 1 of 2 · 78 matching rows.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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