Hemorrhoidal

Manufacturer
FAMILY DOLLAR SERVICES INC | Geri-Care Pharmaceutical Corp
Effective date
2020-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:02:09

Label at a glance#

ProductHemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

detach one suppository from the strip. Remove the wrapper before inserting into the rectum. Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bo...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH SUPPOSITORY)

OTC - ACTIVE INGREDIENT SECTION

Cocoa butter 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant
Vasoconstructor

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug for high blood pressure or depression

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 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

OTHER SAFETY INFORMATION

Store at 59-77° F (20-25° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

methylparaben, propylparaben, starch

Hemorrhoidal Suppositories Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS

HEMORRHOIDAL SUPPOSITORIES

*Compare to the active ingredient of PREPARATION H® HEMORRHOIDAL SUPPOSITORIES

Reduces Internal Swelling/Soothes and Protects

  • Prompt Soothing Relief from Burning, Itching, and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Also for Nighttime Relief

12 SUPPOSITORIES

341341

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-343-122020-12-14C16284748780-19d75b9d0-e4f4-f424-e053-dadaa90a57cefamily wellness 341
55319-343-122020-01-31C16284748780-19d75b9d0-e4f4-f424-e053-dadaa90a57cefamily wellness 341

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-34355319-343-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6732a11-1985-75f3-e053-2995a90a8d0757e6cd1e-fdd4-099e-e053-2a91aa0af26e2020-12-14WarningsExact identifier
spl id: b6732a11-1985-75f3-e053-2995a90a8d07
spl set id: 57e6cd1e-fdd4-099e-e053-2a91aa0af26e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.