STRATUSCARE GLYCERIN LAXATIVE PEDIATRIC- glycerin suppository 
Stratus Pharmaceuticals

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.

----------

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 NOT FINALpart33406/01/2014
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Tarmac Products059890491MANUFACTURE(58980-409)

Revised: 11/2022
Document Id: 688973a2-6be6-480a-af80-f97f24fa5205
Set id: 6ae6d3c4-bb3b-4436-b76d-8654bf871e66
Version: 3
Effective Time: 20221102
 
Stratus Pharmaceuticals