ACEPHEN
-
acetaminophen suppository
Cardinal Health
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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SEE NEW WARNINGS INFORMATION
If pregnant or breast-feeding, ask a health professional before use.
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.
WARNINGS:
For rectal use only
Liver Warnings: This product contains acetaminophen. Severe liver damage may occur if you take
-an adult or child 12 years and older takes more than 6 suppositories in 24 hours, which is the maximum daily amount
-with other drugs containing acetaminophen
-an adult takes 3 or more alcoholic drinks every day while using this product
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
Ask a doctor before use if 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.
Do not use more than directed
remove foil wrapper
carefully insert suppository well up into rectum
adults and children 12 years and older
1 suppository every 4 to 6 hours while symptoms persist
do not exceed 6 suppositories in any 24-hour period
children under 12 years: do not use
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
Store at Room Temperature 15-30 C (59-86 F)
TAMPER-EVIDENT: Individually sealed in foil for your protection.
Do not use if foil is torn or open.
Established since 1919, G&W Laboratories, Inc. is one of the largest manufacturers of quality suppositories in the United States. We take special care to ensure that all products are of the finest quality you can buy.
SATISFACTION GUARANTEED OR YOUR MONEY BACK FROM G&W
G & W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Visit our website @ www.gwlabs.com
Questions? call 1-800-922-1038
AcephenTM
Acetaminophen Suppositories USP 650 mg
10 Rectal Suppositories
Repackaged by Cardinal Health
Zanesville, OH 43701
L3299120-11111
L3299120-21111
AcephenTM
Acetaminophen Suppositories USP 650 mg
10 Rectal Suppositories
ACEPHEN
acetaminophen suppository |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
Unapproved drug other | 06/06/2011 |
Labeler - Cardinal Health (188557102) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Cardinal Health | 188557102 | REPACK |
Revised: 01/2012 Cardinal Health