Neilmed Hemorrhoidal Suppositories 24count

Neilmed Hemorrhoidal Suppositories 24count
SPL v2
SPL
SPL Set ID 03b159b0-b960-b38d-e063-6394a90a9462
Route
RECTAL
Published
Effective Date 2023-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (2.5 mg) Cocoa Butter (884.4 mg)
Inactive Ingredients
Methylparaben Modified Corn Starch (1-octenyl Succinic Anhydride) Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-24

Description

Cocoa butter 88.44% Phenylephrine Hydrochloride 0.25%

Purpose

Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Vasoconstrictor

Description

Cocoa butter 88.44% Phenylephrine Hydrochloride 0.25%

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, irritatedanorectal surface to help make bowel movements less painful.

Section 51945-4

Section 60560-0

Shrinks Swollen Tissue

• Reduces internal swelling, soothes & protects

• Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis

Warnings:

For rectal use only

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 • 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.

Drug Facts :

Cocoa butter 88.44%

Phenylephrine Hydrochloride 0.25%

Other Information:

store at 20° - 25°C (68° - 77°F)

Inactive Ingredients:

methylparaben, propylparaben, topical starch

When Using This Product:

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

• children under 12 years of age: ask a doctor

Stop Use and Ask 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)

Ask A Doctor Before Use If You Have

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of prostate gland unless directed by a doctor

Ask A Doctor Or Pharmacist Before Use

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.


Structured Label Content

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, irritatedanorectal surface to help make bowel movements less painful.

Section 51945-4 (51945-4)

Section 60560-0 (60560-0)

Shrinks Swollen Tissue

• Reduces internal swelling, soothes & protects

• Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis

Purpose

Protectant

Vasoconstrictor

Warnings:

For rectal use only

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 • 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.

Drug Facts :

Cocoa butter 88.44%

Phenylephrine Hydrochloride 0.25%

Other Information: (Other information:)

store at 20° - 25°C (68° - 77°F)

Inactive Ingredients: (Inactive ingredients:)

methylparaben, propylparaben, topical starch

When Using This Product: (When using this product:)

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

• children under 12 years of age: ask a doctor

Stop Use and Ask Doctor If (Stop use and ask doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical

help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of prostate gland unless directed by a doctor

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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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