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  5. Label Information: Glycerin

FDA Label for Glycerin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. WHEN USING THIS PRODUCT
    8. STOP USING THIS PRODUCT AND CONSULT A DOCTOR IF YOU HAVE
    9. IF PREGNANT OR BREASTFEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL

Glycerin Product Label

The following document was submitted to the FDA by the labeler of this product Major� Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



(in each suppository)

Glycerin, USP 2 g


Purpose



Hyperosmotic laxative


Uses



For relief of occasional constipation. This product usually produces a bowel movement in ¼ to 1 hour.


Warnings



For rectal use only.


Do Not Use



laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor


Ask A Doctor Before Use If



  • you have a sudden change in bowel habits lasting more than 2 weeks.
  • already used a laxative for more than 1 week.

When Using This Product



rectal discomfort or burning sensation may occur


Stop Using This Product And Consult A Doctor If You Have



  • rectal bleeding
  • no bowel movement within 1 hour of using this product

    • This may indicate a serious condition.


If Pregnant Or Breastfeeding,



ask a doctor before use. 


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



Single Daily dosage: 1 suppository or as directed by a doctor

 Adults and children 6 years and over

  • tear wrapper prior to immediate use
  • remove the secondary wrapper before inserting into the rectum as follows:

    •    - hold suppository with pointed end up
    - carefully separate tabs with fingernail
    - gently pull apart by pulling tabs down on both sides
       - remove suppository from wrapper
       - insert one suppository well up into the rectum

    • Children 2 to 6 years use Children's Glycerin Suppositories
    • Children under 2 years of age: ask a doctor

Other Information



• Only remove overwrap prior to immediate use

• Keep from excessive heat

• Do not use if overwrap is torn


Inactive Ingredients



polyethylene glycol 400, sodium stearate


Questions?



(855) 879-4368


Principal Display Panel



MAJOR®

Glycerin
Suppositories

2 g

Laxative 

For fast, gentle reflief of occasional constipation

Unit Dose

25 Individually Wrapped Adult Suppositories

PDP Major Glycerin Adult Carton - MGSAPDP

PDP Major Glycerin Adult Carton - MGSAPDP

MAJOR®

Glycerin
Suppositories

2 g

Laxative

For fast, gentle reflief of occasional constipation

DO NOT OPEN UNTIL IMMEDIATE USE 

1 Individually Wrapped Adult Suppository


* Please review the disclaimer below.