Bliss Glycerin Suppositories, Children

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]

BLISS GVS CHILDREN- glycerin suppository 
Bliss GVS Pharma Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bliss Glycerin Suppositories, Children

Drug Facts

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

Purpose

Laxative

Uses

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

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.

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

Other information

keep away from excessive heat.

Inactive ingredients purified water, sodium hydroxide, stearic acid

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

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

NDC: 72701-103-12

Children GLYCERIN SUPPOSITORIES

LAXATIVE

For ages 2 to 5 years

For fast, gentle relief of occasional constipation

12 Suppositories

BLISS GVS  CHILDREN
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72701-103
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 HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72701-103-12	2 in 1 CARTON	12/31/2019	01/17/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72701-103-25	5 in 1 CARTON	12/31/2019	01/17/2020
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	12/31/2019	01/17/2020

Labeler - Bliss GVS Pharma Limited (675629890)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(72701-103)

Revised: 1/2020

Document Id: 9c673581-8069-1dc2-e053-2a95a90aac6c

34390-5

Set id: 86947f1d-f2a2-2a28-e053-2991aa0a6727

Version: 4

Effective Time: 20200118

 

Bliss GVS Pharma Limited