Label: SORBITOL solution
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-700-16, 54162-700-30 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
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 January 17, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Directions
- DOSAGE & ADMINISTRATION
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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. - INACTIVE INGREDIENT
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SORBITOL
sorbitol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-700 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL 258.2 g in 474 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-700-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2015 2 NDC:54162-700-30 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/17/2012 Labeler - Geritrex LLC (112796248) Registrant - Geritrex LLC (112796248) Establishment Name Address ID/FEI Business Operations Geritrex LLC 112796248 manufacture(54162-700)