TOPCARE HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

topcare hemorrhoidal by

Drug Labeling and Warnings

topcare hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each suppository)

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

Uses

• 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

Warnings

For rectal use only

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days

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. (1-800-222-1222)

Directions

• 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

methylparaben, propylparaben, topical starch

Questions or comments?

1-888-423-0139

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COMPARE TO PREPARATION H® HEMORRHOIDAL SUPPOSITORIESACTIVE INGREDIENTS

NIGHTTIME RELIEF

Hemorrhoidal Suppositories

OUR PHARMACISTS RECOMMEND

Reduces Internal Swelling. Soothes and Protects

Prompt Soothing Relief from Painful Burning, Itching and Discomfort

Shrinks Swollen Hemorrhoidal Tissue

Protects Irritated Tissue

E – Z OPEN WRAPPER

12 SUPPOSITORIES

INGREDIENTS AND APPEARANCE

TOPCARE HEMORRHOIDAL 
cocoa butter, phenylephrine hcl suppository

Product 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
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 final	part346	11/03/2014

Labeler - Topco Associates LLC (006935977)