ACEPHEN (Acetaminophen) suppository
Cosette Pharmaceuticals, Inc.
ACTIVE INGREDIENT (in each rectal suppository)
Acetaminophen 120 mg
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
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
• 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.
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 ingredients
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
PRINCIPAL DISPLAY PANEL
NDC 0713-0118-50
G&W Pediatric ACEPHEN
TM Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever • Fever Reducer
50 Rectal Suppositories
08/2013

