Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a32d7759-80d0-4806-901d-0c160f67e4b3
Route
RECTAL
Published
Effective Date 2009-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1.614 g)
Inactive Ingredients
Sodium Stearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2003-04-20

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 50566-9



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
  • Adults and children 6 years of age and older: 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 6 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 vominting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.
Package Label
TRIAD®



NDC 50730-1092-1

Cat. No. 10-10925



GLYCERIN

SUPPOSITORIES



Laxative for fast, gentle relief of occasional constipation



Adult sized

Triad Group Inc.

Brookfield, WI 53045 USA

25

suppositories





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, water
Ask A Doctor Before Use
  • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby



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 50566-9 (50566-9)



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)
  • Adults and children 6 years of age and older: 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 6 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 vominting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.
Package Label (PACKAGE LABEL)
TRIAD®



NDC 50730-1092-1

Cat. No. 10-10925



GLYCERIN

SUPPOSITORIES



Laxative for fast, gentle relief of occasional constipation



Adult sized

Triad Group Inc.

Brookfield, WI 53045 USA

25

suppositories





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, water
Ask A Doctor Before Use (Ask a doctor before use)
  • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby



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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