Acetaminophen

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active Ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

• for the temporary relief of minor aches and pains due to:

• headache

• muscular aches

• backache

• minor pain of arthritis

• the common cold

• toothache

• premenstrual and menstrual cramps

• temporarily reduces fever

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000mg in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

 liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

 taking the blood thinning drug Warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• new symptoms occur

• redness or swelling is present

 These could be signs of a serious condition.

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

OVERDOSAGE SECTION

Overdose warning: In the 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

DOSAGE & ADMINISTRATION SECTION

• Do not take more than directed (see overdose warning)

adults and children 12 years and over:

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, polyethylene glycol, povidone, pregelantinized starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 616-2471 

Distributed by:MAJOR PHARMACEUTICALS,

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

M-95          Rev 10/16

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

• Acetaminophen
• HYPROMELLOSES
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE
• STARCH, CORN
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• STEARIC ACID

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 105 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.