graxcell pharmaceutical - hemorrhoidal suppositories, 70795-1021

SPL v8

SPL

SPL Set ID 5162baee-0d63-494e-8046-459437b85348

Route

rectal

Published

Effective Date 2020-11-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

cocoa butter (1768.8 mg) phenylephrine (5 mg)

Inactive Ingredients

methylparaben propylparaben starch, corn

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2017-03-29

Purpose

Protectant Vasoconstructor

Description

Cocoa butter 88.44 % Phenylephrine hydrochloride 0.25 %

Medication Information

Warnings

For rectal use only

Uses

temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Purpose

Protectant

Vasoconstructor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive Ingredients

methylparaben, propylparaben, starch

Description

Cocoa butter 88.44 % Phenylephrine hydrochloride 0.25 %

Section 51945-4

Directions Adults

detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
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: consult doctor

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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.

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland

Active Ingredients (per Suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression

Structured Label Content

Warnings

For rectal use only

Uses

temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Purpose

Protectant

Vasoconstructor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive Ingredients (Inactive ingredients)

methylparaben, propylparaben, starch

Section 51945-4 (51945-4)

Directions Adults

detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
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: consult doctor

When Using This Product (When using this product)

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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.

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

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland

Active Ingredients (per Suppository) (Active Ingredients (per suppository))

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression

Advanced Ingredient Data

[{"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "ACTIB", "strengthNumerator": "1768.8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily shrinks hemorrhoidal tissues gives temporary relief to the itching, burning and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas", "Purpose": "Protectant Vasoconstructor", "Warnings": "For rectal use only", "Directions Adults": "detach one suppository from the strip. Remove the wrapper before inserting into the rectum. 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: consult doctor", "Other Information": "Store at room temperature or in a cool place but not over 80° F", "Inactive ingredients": "methylparaben, propylparaben, starch", "When using this product": "do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly", "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.", "Ask a doctor before use if you have": "heart disease thyroid disease high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland", "Active Ingredients (per suppository)": "Cocoa butter 88.44 % Phenylephrine hydrochloride 0.25 %", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug for high blood pressure or depression"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:54.932641 · Updated: 2026-03-14T23:11:54.825001