Stratuscare Glycerin Suppositories Laxative Pediatric

Stratuscare Glycerin Suppositories Laxative Pediatric
SPL v4
SPL
SPL Set ID 6ae6d3c4-bb3b-4436-b76d-8654bf871e66
Route
RECTAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1 g)
Inactive Ingredients
Water Sodium Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-06-01

Description

Drug Facts

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Drug Facts

Use
  • For relief of occasional constipation (irregularity)
  • generally produces bowel movement in ¼ to 1 hour.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
Section 50566-9

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.
Section 50569-3

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.
Section 50570-1
  • Do not use laxative products for longer than 1 week unless directed by a doctor
Warnings

For rectal use only.

May cause rectal discomfort or burning sensation.

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

Active Ingredient (per Suppository)

Glycerin, USP 1g

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.


Structured Label Content

Use
  • For relief of occasional constipation (irregularity)
  • generally produces bowel movement in ¼ to 1 hour.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).
Section 50566-9 (50566-9)

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.
Section 50569-3 (50569-3)

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.
Section 50570-1 (50570-1)
  • Do not use laxative products for longer than 1 week unless directed by a doctor
Purpose

Laxative

Warnings

For rectal use only.

May cause rectal discomfort or burning sensation.

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 (Other information)
  • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)
Inactive Ingredients (Inactive ingredients)

purified water, sodium stearate

Questions Or Comments? (Questions or comments?)

1-800-442-7882

Active Ingredient (per Suppository) (Active ingredient (per suppository))

Glycerin, USP 1g

Principal Display Panel 25 Suppository Jar Label (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.


Advanced Ingredient Data


Raw Label Data

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