FDA Label for Acephen
View Indications, Usage & Precautions
Acephen Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Rectal Suppository)
Acetaminophen 325 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
• a child 6 to 12 years takes more than 5 doses in 24 hours
• 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.
Do not use
• in children under 6 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
• new symptoms occur
• pain gets worse or lasts more than 10 days
• 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. 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 foil wrapper
• insert suppository well up into rectum
| children under 6 years | do not use |
| children 6-12 years | 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
adults and children 12 years and older | 2 suppositories every 4 to 6 hours (maximum of 6 doses) |
Other Information
• store at room temperature 15˚-30˚C (59˚-86˚F)
Inactive Ingredients
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
Questions?
call 1-800-922-1038
Principal Display Panel - 325 Mg Suppository Box Label
CommUnityCare Federally Qualified Health Centers
Acetaminophen
325mg Supp.
Date:
Name:
Dr.
Hancock item only
123456
1/1/01
Acetaminophen 325mg Suppositories NDC 76413-302-12
Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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