Acetaminophen Suppository
FDA Label NDC 45802-730

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Padagis Israel Pharmaceuticals Ltd for the product Acetaminophen (NDC 45802-730). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each rectal suppository), purposes, uses, warnings, do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Rectal Suppository)

→ Purposes

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredient

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Rectal Suppository)

Acetaminophen 650 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

reduces fever
relieves minor aches, pains, and headache

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
an adult takes 3 or more alcoholic drinks every day while using this product

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.

For rectal use only

Do Not Use

in children under 12 years
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If

you have liver disease
you are taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

fever lasts more than 3 days (72 hours), or recurs.
pain gets worse or lasts more than 10 days.
new symptoms occur.
redness or swelling is present in the painful area.

These may be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
remove wrapper
carefully insert suppository well up into the rectum
adults and children 12 years and older:
1 suppository every 4 to 6 hours while symptoms last
do not exceed 6 suppositories in any 24 hour period
children under 12 years: ask a doctor

Other Information

store at 20-25^°C (68-77^°F) or in a cool place
tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.