STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC- glycerin suppository 
Stratus Pharmaceuticals

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Stratuscare Glycerin Suppositories Laxative Pediatric

Drug Facts

Active ingredient (per suppository)

Glycerin, USP 1g

Purpose

Laxative

Use

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

Other information

Inactive ingredients

purified water, sodium stearate

Questions or comments?

1-800-442-7882

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.

Principal Display Panel - 25 Suppository Jar Label
STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC 
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-409
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-409-1212 in 1 JAR; Type 0: Not a Combination Product06/01/2014
2NDC:58980-409-2525 in 1 JAR; Type 0: Not a Combination Product06/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00706/01/2014
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Tarmac Products059890491MANUFACTURE(58980-409)

Revised: 11/2024
Document Id: 4c627848-1463-4afc-bfd6-e310b1ef0ffa
Set id: 6ae6d3c4-bb3b-4436-b76d-8654bf871e66
Version: 4
Effective Time: 20241101
 
Stratus Pharmaceuticals