1. Home
  2. Labeler Index
  3. Major� Pharmaceuticals
  4. 0904-7332
  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 USING ANY LAXATIVE IF CHILD HAS
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND CONSULT A DOCTOR IF CHILD HAS
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. 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



Glycerin 1.2 g


Purpose



Hyperosmotic Laxative


Uses



For relief of occasional constipation. This product usually produces a bowel movement in 1/4 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 Using Any Laxative If Child Has



  • abdominal pain, nausea or vomiting.
  • 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 Use And Consult A Doctor If Child Has



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

    • This may indicate a serious condition.


Keep Out Of Reach Of Children.



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


Directions



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

Children 2 to 6 years:

  • 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 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®       NDC 0904-7332-17

Children's Glycerin

Suppositories

1.2 g

Laxative

For fast, gentle relief of occasional constipation

Unit Dose

25 Individually Wrapped Child Size Suppositories

MAJOR®       NDC 0904-7332-01

Children's Glycerin

Suppositories

1.2 g

Laxative

For fast, gentle relief of occasional constipation

DO NOT OPEN UNTIL IMMEDIATE USE

Unit Dose

1 Individually Wrapped Child Size Suppository


* Please review the disclaimer below.