Label: TOPCARE HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository
- NDC Code(s): 36800-279-53, 36800-279-62
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 22, 2024
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- Active ingredients (in each suppository)
- Purposes
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Uses
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- helps relieve the local itching and discomfort associated with hemorrhoids
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- temporarily relieves burning and shrinks hemorrhoidal tissue
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- temporarily provides a coating for relief of anorectal discomforts
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- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For rectal use only
Ask a doctor before use if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- 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.
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Directions
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- 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.
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- detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
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- hold suppository with rounded end up
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- see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
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- slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
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- remove exposed suppository from wrapper
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- insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
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- children under 12 years of age: ask a doctor
- Inactive ingredients
-
Package/Label Principal Display Panel
TopCare ® health
COMPARE TO PREPARATION H® SUPPOSITORIES ACTIVE INGREDIENTS
NIGHTTIME RELIEF
Hemorrhoidal Suppositories
● Reduces Internal Swelling. Soothes and Protects
● Prompt Soothing Relief from Painful Burning, Itching and Discomfort
● Shrinks Swollen Hemorrhoidal Tissue
● Protects Irritated Tissue
12 SUPPOSITORIES
E-Z OPEN WRAPPER
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INGREDIENTS AND APPEARANCE
TOPCARE HEMORRHOIDAL
cocoa butter, phenylephrine hcl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-279 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2211 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.5 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-279-62 24 in 1 CARTON 11/03/2014 03/05/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:36800-279-53 12 in 1 CARTON 11/03/2014 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 11/03/2014 Labeler - Topco Associates LLC (006935977)
