Sorbitol by H&H Laboratories, Inc. / H&H Laboratories, Inc. SORBITOL solution

Sorbitol by

Drug Labeling and Warnings

Sorbitol by is a Otc medication manufactured, distributed, or labeled by H&H Laboratories, Inc., H&H Laboratories, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient in each tablespoon=15 ml   Sorbitol 15gm

PURPOSE

Purpose-Laxative

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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

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

WARNINGS

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 INGREDIENT

Inactive Ingredients: Purified Water

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

SORBITOL 
sorbitol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52471-111
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)	SORBITOL	1 g  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52471-111-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/10/2013

Labeler - H&H Laboratories, Inc. (151357175)

Registrant - H&H Laboratories, Inc. (151357175)