SORBITOL- sorbitol solution 
Geritrex LLC

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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Sorbitol Solution

Active Ingredients

Active Ingredients . . . . . . . .Purpose
Sorbitol 70% . . . . . . . . . . . . .Laxative

Uses

For occasional relief of constipation.

Directions

For adults or children 12 years or over. Use 2-4 TBSP (30-60ml)
daily or as directed by a Physician.

Use 2-4 TBSP (30-60ml)
daily or as directed by a Physician.

Warnings

This product does not contain a child resistant cap. Keep out
of reach of children. In case of accidental overdose, contact a
doctor or a poison control center.
Cautions
Stop use if you are having rectal bleeding or failure to have a
bowel movement after use. If adverse effects call 1-800-736-
3437
Unless directed by your doctor
Do not take any laxative if you are having abdominal pain,
nausea, or vomiting.
Laxative products should not be used longer than a week.
Ask a pharmacist or doctor if
• You have noticed a sudden change in bowel habits that
persist over two weeks after using this product.
• You are pregnant or breast feeding before use.

Water

Store at room temperature (59°F-86°F). Below 59°F cloudiness
may occur. Application of heat may restore clarity and fluidity
without affecting the quality of Sorbitol.
DO NOT FREEZE.

Keep out of reach of children. In case of accidental overdose, contact a
doctor or a poison control center.   

image description

image description

SORBITOL 
sorbitol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL258.2 g  in 474 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-700-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
2NDC:54162-700-3030 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/17/2012
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-700)

Revised: 1/2018
Document Id: f0aa7245-b91f-499c-b009-77b00e41c9c8
Set id: ae9a1c12-8662-4f5d-8435-e51dc2b45780
Version: 2
Effective Time: 20180117
 
Geritrex LLC