FDA Label for Stratuscare Glycerin Laxative Pediatric
View Indications, Usage & Precautions
Stratuscare Glycerin Laxative Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals. 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
Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186
Active Ingredient (Per Suppository)
Glycerin, USP 1g
Purpose
Laxative
Use
- For relief of occasional constipation (irregularity)
- generally produces bowel movement in ¼ to 1 hour.
Warnings
For rectal use only.
May cause rectal discomfort or burning sensation.
Otc - Ask Doctor
Ask a doctor before use if your child has:
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks.
Otc - Stop Use
Stop use and ask a doctor:
- if your child has rectal bleeding or fails to have a bowel movement after using a laxative. This may indicate a serious condition.
Otc - Do Not Use
- Do not use laxative products for longer than 1 week unless directed by a doctor
Otc - Keep Out Of Reach Of Children
- Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
Directions
- Children 2 to under 6 years of age:
- Carefully insert one suppository well into child's rectum
- It need not melt completely to produce laxative action
- Generally produces bowel movement in 15 minutes to 1 hour
- Do not exceed one suppository daily unless directed by a doctor
- Children under 2 years old: Consult a doctor.
Other Information
- Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
Inactive Ingredients
purified water, sodium stearate
Questions Or Comments?
1-800-442-7882
Principal Display Panel - 25 Suppository Jar Label
NDC 58980-409-25
STRATUSCARE
INFANTS
& CHILDREN
pediatrics
Glycerin
Suppositories
Laxative
Distributed by:
STRATUS
PHARMACEUTICALS INC
25 SUPPOSITORIES
DO NOT USE IF INNER SEAL IS BROKEN OR MISSING.
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