AcephenTM Acetaminophen Suppositories USP325 mg
Drug Labeling and Warnings
Drug Details [pdf]
ACEPHEN- acetaminophen suppository
Preferred Pharmaceuticals Inc.
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AcephenTM Acetaminophen Suppositories USP
325 mg
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)
do not use if imprinted suppository wrapper is opened or damaged
INACTIVE INGREDIENTS
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
PRINCIPAL DISPLAY PANEL
NDC: 68788-8934
ACEPHENTM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever Fever Reducer
12 Rectal Suppositories
| ACEPHEN
acetaminophen suppository |
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| Labeler - Preferred Pharmaceuticals Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 791119022 | RELABEL(68788-8934) | |