Label: SORBITOL solution
- 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.
Updated January 17, 2018
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- Active Ingredients
- DOSAGE & ADMINISTRATION
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.
Stop use if you are having rectal bleeding or failure to have a
bowel movement after use. If adverse effects call 1-800-736-
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
INGREDIENTS AND APPEARANCE
Product 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)