SORBITOL by Geri-Care Pharmaceuticals, Corp / GCP Laboratories / GCP LABORATORIES SORBITOL solution

SORBITOL by

Drug Labeling and Warnings

SORBITOL by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp, GCP Laboratories, GCP LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SORBITOL 
sorbitol solution

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

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

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

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

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

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - GCP Laboratories (965480861)

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