Label: SORBITOL solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52471-111-16 - Packager: H&H Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 10, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SORBITOL
sorbitol solutionProduct 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)
