Active Ingredient (In Each Rectal Suppository)
Acetaminophen 120 mg
Acetaminophen
FDA Label NDC 54868-5624
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Acetaminophen (NDC 54868-5624). 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), purpose, uses, warnings, keep out of reach of children, dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
pain reliever/fever reducer
Uses
temporarily
• reduces fever
• relieves minor aches, pains, and headache
Warnings
For rectal use only
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts:
• more than 5 suppositories in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
Do not use
• if your child is 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 your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Stop use and ask a doctor if
• fever lasts more than 3 days (72 hours), or recurs
• you need to use this product for pain for more than 5 days continuously
Severe or recurrent pain, or high or continued fever may indicate a serious illness.
Keep Out Of Reach Of Children
If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
This product does not contain directions or complete warnings for adult use.
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectum
• children 3-6 years:
• 1 suppository every 4 to 6 hours while symptoms persist
• do not exceed 5 suppositories in any 24-hour period
• children under 3 years: ask a doctor
Other Information
• for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
• store at 8˚-25˚C (46˚-77˚F)
Inactive Ingredient
butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80
Questions
call 1-800-922-1038
Monday-Friday 9am-4pm EST
Package Label.Principal Display Panel
SEE NEW WARNINGS INFORMATION
READ AND KEEP CARTON FOR NEW LIVER WARNING
NDC 54868-5624-0
12 rectal suppositories
Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever • Fever Reducer
50 Rectal Suppositories
Packaging Carton (5624)
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