NDC 72701-104 Bliss Gvs

Glycerin

NDC Product Code 72701-104

NDC Code: 72701-104

Proprietary Name: Bliss Gvs What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72701 - Bliss Gvs Pharma Limited
    • 72701-104 - Bliss Gvs

NDC 72701-104-05

Package Description: 20 BLISTER PACK in 1 CARTON > 5 SUPPOSITORY in 1 BLISTER PACK

NDC 72701-104-12

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

NDC 72701-104-25

Package Description: 5 BLISTER PACK in 1 CARTON > 5 SUPPOSITORY in 1 BLISTER PACK

NDC 72701-104-50

Package Description: 10 BLISTER PACK in 1 CARTON > 5 SUPPOSITORY in 1 BLISTER PACK

NDC Product Information

Bliss Gvs with NDC 72701-104 is a a human over the counter drug product labeled by Bliss Gvs Pharma Limited. The generic name of Bliss Gvs is glycerin. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Bliss Gvs Pharma Limited

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.

Bliss Gvs 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.

  • GLYCERIN 2 g/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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Bliss Gvs Pharma Limited
Labeler Code: 72701
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-15-2019 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.

Bliss Gvs Product Label Images

Bliss Gvs 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

Other

Drug Facts

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSINGManufactured and Marketed by:BLISS GVS PHARMA LTD.102, Hyde Park, Sake Vihar Road, Andheri(E),Mumbai-400 072, INDIAEmail: info@blissgvs.com • www.blissgvs.com

Otc - Active Ingredient

Active ingredientGlycerin USP, 2 grams

Otc - Purpose

PurposeLaxative

Indications & Usage

  • Usesfor relief of occasional constipationthis product usually produces bowel movement in 1/4 to 1 hour

Warnings

WarningsFor rectal use only

Otc - Do Not Use

Do not use longer than 1 week unless directed by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you haveabdominal pain, nausea or vomitinga sudden change in bowel habits lasting more than 2 weeks

Otc - When Using

When using this product it may cause rectal discomfort or a burning sensation

Otc - Stop Use

  • Stop use and ask a doctor if you haverectal bleedingno bowel movement after using this productThese may indicate a serious condition.

Otc - 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.

Dosage & Administration

  • Directionsadults and children 6 years and over: 1 suppository once dailychildren under 6 years: do not useinsert 1 suppository well up into rectum and retain for 15 minutesit need not melt to produce laxative action

Storage And Handling

Other informationkeep away from excessive heat

Inactive Ingredient

Inactive ingredients purified water, sodium hydroxide, stearic acid

Otc - Questions

Questions or Comments? Call
1-888-830-6075

* Please review the disclaimer below.

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