NDC 72701-110 Bliss Gvs Hemorrhoidal

Hard Fat, Phenylephrine Hcl

NDC Product Code 72701-110

NDC 72701-110-12

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

NDC 72701-110-24

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

NDC Product Information

Bliss Gvs Hemorrhoidal with NDC 72701-110 is a a human over the counter drug product labeled by Bliss Gvs Pharma Limited. The generic name of Bliss Gvs Hemorrhoidal is hard fat, phenylephrine hcl. 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 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.

  • HARD FAT 2493.75 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 6.25 mg/1

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: 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: 05-13-2019 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 Hemorrhoidal Product Label Images

Bliss Gvs 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

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.blissgvs.com

Otc - Active Ingredient

Active ingredients (in each suppository)Hard Fat 99.75%Phenylephrine HCl 0.25%

Otc - Purpose

PurposesProtectantVasoconstrictor

Indications & Usage

  • Usestemporarily shrinks hemorrhoidal tissuetemporarily relieves the itching, burning and discomfort associated with hemorrhoids

Warnings

WarningsFor rectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasethyroid diseasehigh blood pressurediabetestrouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Otc - When Using

When using this product do not use more than directed

Otc - Stop Use

  • Stop use and ask a doctor ifbleeding occurscondition worsens or does not improve within 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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

  • Directionswhen practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.detach one suppository from the stripseparate the two tabs of the white plastic wrapwith thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppositoryinsert one suppository into the rectumadults and children 12 years and over: insert one suppository rectally up to 4 times daily
  • Children under 12 years: ask a doctor

Storage And Handling

Other informationstore below 30°C (86°F) to avoid melting.

Inactive Ingredient

Inactive ingredientsno additional inactive ingredient used

Otc - Questions

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

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