GLYCERIN- glycerin suppository suppository 
MAJOR® PHARMACEUTICALS

----------

MAJOR® Children's Glycerin

Drug Facts

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:

      - 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

Other information

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

PDP carton

PRINCIPAL DISPLAY PANEL

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

PDP pouch

GLYCERIN 
glycerin suppository suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7332
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.2 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7332-1725 in 1 CARTON07/13/2024
1NDC:0904-7332-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00707/13/2024
Labeler - MAJOR® PHARMACEUTICALS (191427277)

Revised: 7/2024
Document Id: 1d26f1c9-7a1a-5202-e063-6294a90ae17b
Set id: 57931e5f-f0c5-4b0d-ae82-3e11a873e1ac
Version: 1
Effective Time: 20240713
 
MAJOR® PHARMACEUTICALS