Label: COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL suppository
Contains inactivated NDC Code(s)
NDC Code(s): 50730-1481-1
- Packager: H and P Industries, Inc. dba Triad Group
- 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.
Updated November 20, 2009
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- ACTIVE INGREDIENTS
For rectal use only.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
Ask a doctor or pharmacist before use if
you are presently taking a prescription drug for high blood pressure or depression.
Stop use and ask a doctor if
- you experience bleeding
- condition worsens or does not improve within 7 days.
- When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
- Detach one suppository from strip
- Remove wrapper before inserting into rectum
- Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
- Carefully peel film slowly and evenly down both sides to expose suppository
- Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENTS
Cat. No. 10-14812
Temporarily relieves itching and discomfort associated with hemorrhoids
Individually wrapped unit dose
Triad Group, Inc.
Brookfield, WI 53045 USA
FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER.
DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.
INGREDIENTS AND APPEARANCE
COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL
cocoa butter, phenylephrine hydrochloride, shark liver oil suppository
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-1481 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength cocoa butter (UNII: 512OYT1CRR) (cocoa butter - UNII:512OYT1CRR) cocoa butter 2077 mg phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 6 mg shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU) shark liver oil 73 mg Inactive Ingredients Ingredient Name Strength methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) starch, corn (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50730-1481-1 12 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/06/2004 Labeler - H and P Industries, Inc. dba Triad Group (050259597) Registrant - H and P Industries, Inc. dba Triad Group (050259597) Establishment Name Address ID/FEI Business Operations H and P Industries, Inc. dba Triad Group 050259597 manufacture