NDC 68016-322 Hemorrhoidal

Cocoa Butter, Phenylephrine Hcl

NDC Product Code 68016-322

NDC 68016-322-12

Package Description: 2 BLISTER PACK in 1 CARTON > 6 SUPPOSITORY in 1 BLISTER PACK

NDC 68016-322-24

Package Description: 4 BLISTER PACK in 1 CARTON > 6 SUPPOSITORY in 1 BLISTER PACK

NDC Product Information

Hemorrhoidal with NDC 68016-322 is a a human over the counter drug product labeled by Pharmacy Value Alliance Llc. The generic name of Hemorrhoidal is cocoa butter, phenylephrine hcl. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Pharmacy Value Alliance Llc

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hemorrhoidal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • COCOA BUTTER 2.39 g/1
  • PHENYLEPHRINE HYDROCHLORIDE 6.75 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmacy Value Alliance Llc
Labeler Code: 68016
FDA Application Number: part346 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-16-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hemorrhoidal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (Per Suppository)

Cocoa butter 88.44%Phenylephrine hydrochloride 0.25%

Purpose

ProtectantVasoconstrictor

Uses

  • Temporarily shrinks hemorrhoidal tissuegives temporary relief to the itching, burning and discomfort associated with hemorrhoidsaids 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 diseasethyroid diseasedifficulty in urination due to enlargement of the prostate glandhigh blood pressurediabetes

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctorin 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

Directions

  • Adultsdetach one suppository from the strip. Remove the wrapper before inserting into the rectuminsert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movementchildren 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

* Please review the disclaimer below.