Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d2960e35-1b45-4d58-b63b-741795bf9f0a
Route
RECTAL
Published
Effective Date 2003-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1.3 g)
Inactive Ingredients
Sodium Stearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-02-01

Description

Glycerin, USP 80.7%

Purpose

Laxative


Medication Information

Warnings and Precautions



Purpose

Laxative

Description

Glycerin, USP 80.7%

Use

For relief of occasional constipation

Section 42229-5



Section 50567-7



Section 50568-5



Section 53413-1



Section 53414-9



Warnings

For rectal use only. May cause rectal discomfort or a burning sensation.

Directions
  • Children 2 - 6 years of age: carefully insert one suppository well into the rectum
  • Do not use more than once per day
  • Generally produces a bowel movement in 15 minutes to 1 hour
  • Children under 2 years of age: ask a doctor.
Do Not Use
  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.
Ask A Doctor
  • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
  • if you are pregnant or nursing a baby



Package Label
NDC 41250-404-12



meijer



children's

Glycerin

Suppositories




laxative



For fast, gentle relief of

occasional constipation



Compare to Fleet®

active ingredient*



Meijer Pharmacist Recommended



12 Suppositories



DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544



*This product is not manufactured or

distributed by C.B.Fleet co., owner of

the registered trademark Fleet®.



USE ONLY IF PRINTED

INNER SEAL IS NOT

BROKEN OR MISSING





Active Ingredient

Glycerin, USP 80.7%

Other Information
  • Store container tightly closed
  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
Inactive Ingredients
sodium stearate, purified water
Stop Use and Ask A Doctor
if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use (USE)

For relief of occasional constipation

Warnings and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50567-7 (50567-7)



Section 50568-5 (50568-5)



Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Purpose (PURPOSE)

Laxative

Warnings (WARNINGS)

For rectal use only. May cause rectal discomfort or a burning sensation.

Directions (DIRECTIONS)
  • Children 2 - 6 years of age: carefully insert one suppository well into the rectum
  • Do not use more than once per day
  • Generally produces a bowel movement in 15 minutes to 1 hour
  • Children under 2 years of age: ask a doctor.
Do Not Use (Do not use)
  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.
Ask A Doctor (Ask a doctor)
  • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
  • if you are pregnant or nursing a baby



Package Label (PACKAGE LABEL)
NDC 41250-404-12



meijer



children's

Glycerin

Suppositories




laxative



For fast, gentle relief of

occasional constipation



Compare to Fleet®

active ingredient*



Meijer Pharmacist Recommended



12 Suppositories



DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544



*This product is not manufactured or

distributed by C.B.Fleet co., owner of

the registered trademark Fleet®.



USE ONLY IF PRINTED

INNER SEAL IS NOT

BROKEN OR MISSING





Active Ingredient (ACTIVE INGREDIENT)

Glycerin, USP 80.7%

Other Information (OTHER INFORMATION)
  • Store container tightly closed
  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
Inactive Ingredients (INACTIVE INGREDIENTS)
sodium stearate, purified water
Stop Use and Ask A Doctor (Stop use and ask a doctor)
if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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