SORBITOL- sorbitol solution
Geri-Care Pharmaceuticals, Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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gc sorbitol

Active ingredient (In each 15 mL tablespoonful)

Sorbitol 13.5 g

Purpose

Laxative

Uses

relieves occasional constipation and irregularity
generally produces bowel movement in 1/4 to 1 hour when used rectally
as a pharmaceutical aide (sweetner)
for other uses, as your doctor

Warnings

Do not use

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor
Ask a doctor before use if you
are taking mineral oil
have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a

Poison Control Center right away.

Directions

do not exceed recommended dose

Age	Dose
adults and children 12 years and over	For rectal use only. Enema dosage is 120 mL of a 25 to 30% w/v solution (1 part of this product with 2.3 parts water) in a single daily dose as needed, or as directed by your doctor.
children under 12 years	Ask a doctor

Other information

store at room temperature 15-30C (59-86F)
below 59F cloudiness and thickening may occur; warming will restore clarity and fluidity without affecting product quality
do not freeze
store in original container

Inactive ingredient

water

Questions or comments?

1-800-540-3765

package Label

SORBITOL
sorbitol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-435
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)	SORBITOL	13.5 g in 15 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57896-435-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000	05/01/2022

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - GCP Laboratories (965480861)

Name	Address	ID/FEI	Business Operations
Establishment
GCP LABORATORIES		965480861	manufacture(57896-435) , pack(57896-435)

Revised: 12/2021

Document Id: d3c0c1ae-2632-8975-e053-2a95a90ac3ea

Set id: 16cc9d47-5382-4237-ab84-f22c5436fe2e

Version: 4

Effective Time: 20211222

Geri-Care Pharmaceuticals, Corp