FDA Label for Bliss Gvs Children
View Indications, Usage & Precautions
Bliss Gvs Children Product Label
The following document was submitted to the FDA by the labeler of this product Bliss Gvs Pharma Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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: [email protected] • www.blissgvs.com
Otc - Active Ingredient
Active ingredient (in each suppository)
Glycerin USP, 1.2 grams
Otc - 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
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 has
- abdominal pain, nausea or vomiting
- a 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 has
- rectal bleeding
- no bowel movement after using this product
These 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
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
Otc - Questions
Questions or Comments? Call 1-888-830-6075
Package Label.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
* Please review the disclaimer below.