NDC 72701-103 Bliss Gvs Children

Glycerin

NDC Product Code 72701-103

NDC 72701-103-12

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

NDC 72701-103-25

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

NDC Product Information

Bliss Gvs Children with NDC 72701-103 is a a human over the counter drug product labeled by Bliss Gvs Pharma Limited. The generic name of Bliss Gvs Children 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 Children 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 1.2 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’.

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Bliss Gvs Children Product Label Images

Bliss Gvs Children 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, Saki Vihar Road, Andheri (E)Mumbai-400 072, INDIAEmail: info@blissgvs.com • www.bliss.com

Otc - Active Ingredient

Active ingredient (in each suppository)Glycerin USP, 1.2 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 for longer than one week unless directed by a doctor

Otc - Ask Doctor

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

Otc - When Using

When using this product your child may have rectal discomfort or a burning sensation

Otc - Stop Use

  • Stop use and ask a doctor if the child hasrectal 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

  • Directionschildren 2 to under 6 years of age: 1 suppository once dailychildren under 2 years: ask a doctorinsert 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


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