Infant Glycerin Laxative description, usages, side effects, indications, overdosage, supplying and lots more!

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Infant Glycerin Laxative

Physicians Total Care, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

Glycerin, USP 80.7%

PURPOSE

Laxative

USE

For relief of occasional constipation

WARNINGS

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

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

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.

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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.

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

QUESTIONS

Adverse Drug Event Call: (800) 616-2471

PRINCIPAL DISPLAY PANEL

NDC 54868-6186-0


Infant
GLYCERIN
SUPPOSITORIES


Rectal evacuant
For relief of
temporary constipation

12 Infant Suppositories

Infant Glycerin Laxative

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

Infant Glycerin Laxative

Glycerin SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-6186(NDC:0904-2666)
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GLYCERIN 1.3 g

Inactive Ingredients

Ingredient Name Strength
sodium stearate
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-6186-0 12 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-10-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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