Premier Value Hemorrhoidal
FDA Label NDC 68016-321

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 Consortium for the product Premier Value Hemorrhoidal (NDC 68016-321). 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, uses, warnings, directions, other information, inactive ingredients, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients                                                                        Purpose

(per suppository)

Cocoa butter 88.44%...................................................................Protectant

Phenylephrine hydrochloride 0.25%..............................................Vasoconstrictor

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

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 a doctor

Other Information

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

Inactive Ingredients

methylparaben, propylparaben, starch

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

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 the prostate gland

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

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