GERICARE SORBITOL SOLUTION- sorbitol liquid

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

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Laxative Uses - releieves 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, ask your doctor

Authorization status:

OTC monograph not final

Summary of Product characteristics

GERICARE SORBITOL SOLUTION- SORBITOL LIQUID
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._
----------
ACTIVE INGREDIENT
Sorbitol 70% USP
PURPOS E
Laxative
US ES
releieves 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, ask your doctor
WARNINGS
FOR RECTAL USE ONLY
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
are taking mineral oil
have noticed a sudden change in bowel habits that lasts over 2 weeks
STOP USE AND ASKA DOCTOR IF
you have a 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 of age
Ask a doctor
INACTIVE INGREDIENTS
water
QUESTIONS OR COMMENTS? 1-800-540-3765
GERICARE SORBITOL SOLUTION
sorbitol liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:578 9 6 -758
ROUTE OF ADMINISTRATION
RECTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SO RBITO L (UNII: 50 6 T6 0 A25R) (SORBITOL - UNII:50 6 T6 0 A25R)
SORBITOL
70 mg in 10 0 mL
GERI-CARE PHARMACEUTICALS, CORP
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5