SPL v1
SPL
SPL Set ID d7a8c09d-d829-4dea-8bc4-4299ecc99dda
Route
RECTAL
Published
Effective Date 2010-10-28
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 2010-10-27

Description

Glycerin, USP 80.7%

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Glycerin, USP 80.7%

Use

For relief of occasional constipation

Section 50567-7

Enter section text here

Section 50568-5

Enter section text here

Section 53414-9

Enter section text here

Warnings

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

Questions

Adverse Drug Event Call: (800) 616-2471

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

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

Principal Display Panel

NDC 54868-6186-0





Infant

GLYCERIN

SUPPOSITORIES



Rectal evacuant

For relief of

temporary constipation



12 Infant Suppositories

Compare to Fleet® Glycerin Suppositories*





*This product is not manufactured or distributed by C.B.Fleet co., owner of

the registered trademark Fleet®.



Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Reorder No. 233874

M-54 Rev 6/08

DO NOT USE IF PRINTED

INNER SEAL IS BROKEN

OR MISSING





Relabeling of "Additional Barcode Label" by:

Physicians Total Care, Inc.

Tulsa, OK      74146

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

Section 50567-7 (50567-7)

Enter section text here

Section 50568-5 (50568-5)

Enter section text here

Section 53414-9 (53414-9)

Enter section text here

Purpose (PURPOSE)

Laxative

Warnings (WARNINGS)

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

Questions (QUESTIONS)

Adverse Drug Event Call: (800) 616-2471

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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 54868-6186-0





Infant

GLYCERIN

SUPPOSITORIES



Rectal evacuant

For relief of

temporary constipation



12 Infant Suppositories

Compare to Fleet® Glycerin Suppositories*





*This product is not manufactured or distributed by C.B.Fleet co., owner of

the registered trademark Fleet®.



Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Reorder No. 233874

M-54 Rev 6/08

DO NOT USE IF PRINTED

INNER SEAL IS BROKEN

OR MISSING





Relabeling of "Additional Barcode Label" by:

Physicians Total Care, Inc.

Tulsa, OK      74146

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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