Label: ACEPHEN- acetaminophen suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-302-12 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 0713-0164
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 9, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each rectal suppository)
- PURPOSE
- USES
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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.
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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
- INACTIVE INGREDIENTS
- QUESTIONS?
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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 LABSFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
ACEPHEN
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-302(NDC:0713-0164) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Inactive Ingredients Ingredient Name Strength Glyceryl Monostearate (UNII: 230OU9XXE4) Hydrogenated Coconut Oil (UNII: JY81OXM1OM) Peg-100 Stearate (UNII: YD01N1999R) Sorbitan Monooleate (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-302-12 12 in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072344 03/27/1992 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-302) , RELABEL(76413-302)