Label: HEMORRHOIDAL suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-045-12 - Packager: Geritrex Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 16, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
- Directions
- DOSAGE & ADMINISTRATION
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WARNINGS
For rectal use only
Ask a doctor or pharmacist before use if your are
presently taking a prescription drug for high blood
pressure or depression
Ask a doctor before use if you have
heart disease high blood pressure
thyroid disease diabetes diffculty urination due to enlargement of
the prostate gland
When using this product
do not exceed the recommended daily dosage unless
directed by a doctor
in case of bleeding or if condition worsens or does not
improve within 7 days, consult a doctor promptly
If pregnant or breast-feeding, ask a health
professional before use. Keep out of reach of
children. If swallowed, get medical help or
contact a Poison Control Center right away - INACTIVE INGREDIENT
- STORAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
hemorrhoidal suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-045 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 85.5 g in 100 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHARK LIVER OIL (UNII: 4B24275HEU) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-045-12 2 g in 1 BOX, UNIT-DOSE 10/03/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 02/29/2012 Labeler - Geritrex Corp. (112796248) Registrant - Geritrex Corp. (112796248)