SORBITOL solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)

Available from:

Geri-Care Pharmaceuticals, Corp

INN (International Name):

SORBITOL

Composition:

SORBITOL 13.5 g in 15 mL

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Laxative - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)
SORBITOL
13.5 g in 15