BLISS GVS CHILDREN- glycerin suppository

Bliss GVS by

Drug Labeling and Warnings

Bliss GVS by is a Otc medication manufactured, distributed, or labeled by Bliss GVS Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

PURPOSE

Purpose

Laxative

INDICATIONS & USAGE

Uses

• for relief of occasional constipation
• this product usually produces bowel movement in 1/4 to 1 hour

WARNINGS

Warnings

For rectal use only

Do not use for longer than one week unless directed by a doctor

Ask a doctor before use if the child has

• abdominal pain, nausea or vomiting
• a sudden change in bowel habits lasting more than 2 weeks

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

Stop use and ask a doctor if the child has

• rectal bleeding
• no bowel movement after using this product

These may indicate a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• children 2 to under 6 years of age: 1 suppository once daily
• children under 2 years: ask a doctor
• insert suppository well up into rectum and retain for 15 minutes
• it need not melt to produce laxative action

STORAGE AND HANDLING

Other information

keep away from excessive heat.

INACTIVE INGREDIENT

Inactive ingredients purified water, sodium stearate

QUESTIONS

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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

Manufactured and Marketed by:

BLISS GVS PHARMA LTD.

102, Hyde Park, Saki Vihar Road, Andheri (E)

Mumbai-400 072, INDIA

Email: info@blissgvs.com www.blissgvs.com

PRINCIPAL DISPLAY PANEL

NDC: 72701-105-12

Children GLYCERIN SUPPOSITORIES

LAXATIVE

For ages 2 to 5 years

For fast, gentle relief of occasional constipation

12 Suppositories

INGREDIENTS AND APPEARANCE

BLISS GVS   CHILDREN
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72701-105
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM STEARATE (UNII: QU7E2XA9TG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72701-105-12	2 in 1 CARTON	01/20/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72701-105-25	5 in 1 CARTON	01/20/2020
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/20/2020

Labeler - Bliss GVS Pharma Limited (675629890)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(72701-105) , analysis(72701-105) , pack(72701-105) , label(72701-105)