SORBITOL- sorbitol solution 
H&H Laboratories, Inc.

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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DRUG FACTS

Active Ingredient in each tablespoon=15 ml   Sorbitol 15gm

Purpose-Laxative

Uses-Relieves occasional constipation and irregularity.  Generally produces bowel movement in 1/4 to 1 hour when used rectally.  As a pharmaceutical aid (sweetener). For other uses, ask your doctor.

Directions: For adults and children 12 years or older: Dose-2 tablespoons.  maximum single dose-4 tablespoons.  Not to exceed 6 tablespoons daily

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings: Do not use:  When abdominal pain, nausea, or vomiting are present for more than a week unless directed by a doctor.

Ask a doctor before use if you-are taking mineral oil, have noticed a sudden change in bowel habi9ts that lasts over 2 weeks.

Stop use and ask a doctor if: Youn have rectal bleeding or no bowel movement after using this product.  These could be signs of a serious condition.






  

Inactive Ingredients: Purified Water

MM1

sorbitol label


SORBITOL 
sorbitol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52471-111
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52471-111-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/10/2013
Labeler - H&H Laboratories, Inc. (151357175)
Registrant - H&H Laboratories, Inc. (151357175)

Revised: 6/2013
Document Id: f251e7d4-222e-4e0f-9317-2e75bdaa86f2
Set id: debf8549-7369-40e7-a594-bff433a7bbf0
Version: 1
Effective Time: 20130610
 
H&H Laboratories, Inc.