Hemorrhoidal
FDA Label NDC 63868-208

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Hemorrhoidal (NDC 63868-208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts active ingredients, purposes, keep out of reach of children., uses, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts Active Ingredients

Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %

Purposes

Protectant
Vasoconstructor

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.

Uses

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

Warnings

For rectal use only

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression

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

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.

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

Hemorrhoidal Suppositories Product Label


NDC 63868-208-12

QC QUALITY CHOICE


*Compare to the active ingredient in PREPARATION H®

HEMORRHOIDAL SUPPOSITORIES
Reduces Internal Swelling l Soothes and Protects

Cocoa Butter 88.4% l Phenylephrine Hydrochloride 0.25%
Prompt Soothing Relief From Painful Burning, Itching, and Discomfort
Provides Additional Nighttime Relief

12 ADULT SUPPOSITORIES

SATISFACTION GUARANTEED QC 100%

Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

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*This product is not manufactured or distributed by Pfizer Consumer Healthcare., distributor of Preparation H®.

* Please review the disclaimer below.