drug facts

drug facts
SPL v1
SPL
SPL Set ID 5dcea9dc-51f7-4de8-ba41-1bebfd2a6671
Route
rectal
Published
Effective Date 2009-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
glycerin (2 g)
Inactive Ingredients
sodium stearate water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2009-07-01

Purpose

Laxative

Description

Glycerin, USP 2g


Medication Information

Warnings and Precautions



Warnings

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

Purpose

Laxative

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.
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
Description

Glycerin, USP 2g

Use

For relief of occasional constipation

Section 42229-5



Section 50567-7



Section 50568-5



Section 53413-1



Section 53414-9



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.
Package Label
CVS pharmacy



NDC 50730-1091-0

Compare to Fleet Glycerin Suppositories

NEW!



GLYCERIN

SUPPOSITORIES

LAXATIVE



For fast, gentle relief of

occasional constipation



12 ADULT SUPPOSITORIES



Distributed by CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895



©CVS/pharmacy

1-800-shop-CVS

www.cvs.com

#721501

DO NOT USE IF PRINTED

INNER SEAL IS BROKEN

OR MISSING



This product is not

manufactured or distributed

by C.B.Fleet co., owner of

the registered trademark

Fleet®.







Active Ingredient

Glycerin, USP 2g

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



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 condition.

Keep Out of Reach of Children

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


Structured Label Content

Warnings and Precautions (34071-1)



Warnings (WARNINGS)

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

Purpose (PURPOSE)

Laxative

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.
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
Use (USE)

For relief of occasional constipation

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)



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.
Package Label (PACKAGE LABEL)
CVS pharmacy



NDC 50730-1091-0

Compare to Fleet Glycerin Suppositories

NEW!



GLYCERIN

SUPPOSITORIES

LAXATIVE



For fast, gentle relief of

occasional constipation



12 ADULT SUPPOSITORIES



Distributed by CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895



©CVS/pharmacy

1-800-shop-CVS

www.cvs.com

#721501

DO NOT USE IF PRINTED

INNER SEAL IS BROKEN

OR MISSING



This product is not

manufactured or distributed

by C.B.Fleet co., owner of

the registered trademark

Fleet®.







Active Ingredient (ACTIVE INGREDIENT)

Glycerin, USP 2g

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



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 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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