Premier Value Hemmorrhoidal Suppositories

Premier Value Hemmorrhoidal Suppositories
SPL v7
SPL
SPL Set ID 903b77fc-02bf-73b6-e053-2a95a90ad4cc
Route
RECTAL
Published
Effective Date 2019-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cocoa Butter (2.39 g) Phenylephrine (6.75 mg)
Inactive Ingredients
Starch, Corn Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-16

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
  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
Section 51945-4

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

Premier Value Hemorrhoidal Suppositories 12ct

Distributed by Pharmacy Value Alliance LLC

407 East Lancaster Avenue

Wayne, PA 19087

785PVHemSupp.jpg

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 80°F

Inactive Ingredients

corn starch, methylparaben, propylparaben

Questions Or Comments?

1-800-492-5988

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

Uses
  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
Section 51945-4 (51945-4)

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

Premier Value Hemorrhoidal Suppositories 12ct

Distributed by Pharmacy Value Alliance LLC

407 East Lancaster Avenue

Wayne, PA 19087

785PVHemSupp.jpg

Purpose

Protectant

Vasoconstrictor

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 (Other information)

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

Inactive Ingredients (Inactive ingredients)

corn starch, methylparaben, propylparaben

Questions Or Comments? (Questions or comments?)

1-800-492-5988

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


Raw Label Data

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