Label: GOOD SENSE HEMORRHOIDAL- cocoa butter and phenylephrine hydrochloride suppository
- NDC Code(s): 0113-0160-53
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each suppository)
Cocoa butter 85.39%
Phenylephrine HCl 0.25%Close
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily relieves burning and shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
For rectal use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
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
- bleeding occurs
- condition worsens or does not improve within 7 days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
- detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
- hold suppository with rounded end up
- see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
- slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
- remove exposed suppository from wrapper
- insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
- children under 12 years of age: ask a doctor
- Other information
- store at 20-25°C (68-77°F)
- Inactive ingredients
corn starch, methylparaben, propylparaben, shark liver oilClose
- Questions or comments?
- Package/Label Principal Display Panel
E-Z Open Wrapper
Prompt Soothing Relief from Painful Burning, Itching and Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
Also for Nighttime Relief
Reduces Internal Swelling.
Soothes and Protects.
Compare to active ingredients of Preparation H® Hemorrhoidal SuppositoriesClose
- INGREDIENTS AND APPEARANCE
GOOD SENSE HEMORRHOIDAL
cocoa butter, phenylephrine hcl suppository
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0160 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2.135 g in 2.5 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE .0065 g in 2.5 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHARK LIVER OIL (UNII: 4B24275HEU) Product Characteristics Color YELLOW Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0160-53 2 in 1 CARTON 1 15 g in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/26/2012 Labeler - L. Perrigo Company (006013346)