STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC- glycerin suppository

Stratuscare Glycerin Laxative Pediatric by

Drug Labeling and Warnings

Stratuscare Glycerin Laxative Pediatric by is a Otc medication manufactured, distributed, or labeled by Stratus Pharmaceuticals, Tarmac Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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.

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.

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.

• Do not use laxative products for longer than 1 week unless directed by a doctor

• 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

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Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

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.

INGREDIENTS AND APPEARANCE

STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC 
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-409
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	1 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: 58980-409-12	12 in 1 JAR; Type 0: Not a Combination Product	06/01/2014
2	NDC: 58980-409-25	25 in 1 JAR; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	06/01/2014

Labeler - Stratus Pharmaceuticals (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
Tarmac Products		059890491	MANUFACTURE(58980-409)