MedPath

Liquid Glycerin Laxatives

Liquid Glycerin Laxatives

Approved
Approval ID

2dd97e1c-3f0b-6728-e063-6294a90abfa2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Feb 19, 2025

Manufacturers
FDA

Shanghai Yijing Medical Technology Co., Ltd.

DUNS: 567720668

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85157-002
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
GLYCERIN
Product Specifications
Route of AdministrationRECTAL
Effective DateFebruary 19, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINActive
Quantity: 7.2 g in 10 mL
Code: PDC6A3C0OX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/11/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/11/2025

USe for relief of occasional constipation. This product usually produces bowel movement in 15 minutes to 1 hour.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 2/11/2025

Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 2/11/2025

Ask a doctor before using any laxative if you
have a sudden change in bowel habits lasting more than 2 weeks
already used a laxative for more than 1 week

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 2/11/2025

Stop using this product and consult a doctor if you have
rectal bleeding
no bowel movement within 1 hour of using this product
These symptoms may indicate a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/11/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/11/2025

Liquid Glycerin Laxatives

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/11/2025

GLYCERIN 5.3g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/11/2025

Hyperosmotic laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 2/11/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/11/2025

Single Daily Dosage (per 24 hours)
Adults and children 12 years and over: 1 suppository or as directed by a doctore

Left-side position: Lie on left side with right knee bent and arms resting comfortably.
Knee-chest position: Kneel, then lower head and chest forward until leftside of face is resting on surface with left arm folded comfortably. Administering the laxative: CAUTION: REMOVE ORANGE PROTECTIVESHIELD BEFORE INSERTING. Hold unit upright, grasping bulb of unit withfingers. Grasp orange protective shield with other hand, pull gently to remove.With steady pressure, insert tip into rectum with a slight side-to-sidemovement, with tip pointing toward navel. Do not force the applicator tip intothe rectum, as this can cause injury. Insert ion may be easier if person receivingsuppository bears down as if having a bowel movement. This helps relax themuscles around the anus. Squeeze the bulb until nearly all liquid is expelled.While continuing to squeeze the bulb, remove tip from rectum and discard unit.
it is not necessary to empty unit completely.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/11/2025

WATER

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Liquid Glycerin Laxatives - FDA Drug Approval Details