SORBITOL solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

H&H Laboratories, Inc.

Адміністрація маршрут:

RECTAL

Тип рецепту:

OTC DRUG

Терапевтичні свідчення:

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.

Статус Авторизація:

OTC monograph not final

Характеристики продукта

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._
----------
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
H&H Laboratories, Inc.
SORBITOL
sorbitol solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52471-111
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
1 g in 1 mL
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:52471-111-16
473 mL in 1 BOTTLE
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt334
0 6 /10 /20 13
LABELER -
H&H Laboratories, Inc. (151357175)
REGISTRANT -
H&H Laboratories, Inc. (15135717