Label: SORBITOL solution
- NDC Code(s): 57896-435-16
- Packager: Geri-Care Pharmaceuticals, Corp
- 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 December 19, 2018
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- Active ingredient (In each 15 mL tablespoonful)
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
Ask a doctor before use if you
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Other information
- Inactive ingredient
- Questions or comments?
- package Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-435 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL 13.5 g in 15 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-435-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - Geri-Care Pharmaceuticals, Corp (611196254) Registrant - GCP Laboratories (965480861) Establishment Name Address ID/FEI Business Operations GCP LABORATORIES 965480861 manufacture(57896-435) , pack(57896-435)