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

Purpose

Laxative

Description

Drug Facts


Medication Information

Warnings

For rectal use only.

May cause rectal discomfort or burning sensation.

Purpose

Laxative

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

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
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

Warnings

For rectal use only.

May cause rectal discomfort or burning sensation.

Purpose

Laxative

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

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
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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