Label: ORAL SALINE LAXATIVE LEMON GINGER- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form liquid
- NDC Code(s): 67234-044-01
- Packager: Natureplex, LLC
- 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 15, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
-
Warnings
Do not use
- if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, or uncorrected electrolyte abnormalities
- in children under 6 years old
- for bowel cleansing
Ask a doctor before use if you
- have abdominal pain, nausea, or vomiting
- have kidney disease
- have heart problems
- have a sudden change in bowel habits lasting more than 2 weeks
- have already used a laxative for more than 3 days
- are dehydrated
- are 55 years of age or older
- are on a sodium-restricted diet
- under a doctor's care for any medical condition
- are taking any other prescription or non-prescription medications
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When using this product
- do not use more than directed. Serious side effects may occur from excess dosage.
- do not use for more than 3 days, without asking a doctor
Stop use and ask a doctor if
- you have rectal bleeding
- you do not have a bowel movement within 6 hours
- you have any symptoms that your body is losing more fluid than you are drinking
- you have early symptoms of dehydration including
- thirstiness
- dizziness
- urinating less often than normal
- vomiting
These symptoms may indicate a serious condition.
-
Directions (or as directed by a doctor)
- Use as a laxative for relief of occasional constipation
- Dilute dose in the table below with one glass (8 fl oz) of cool water. Drink, then follow with at least one additional glass (8 fl oz) of cool water. There is significant loss of fluid when using this product. To prevent dehydration, drink plenty of clear liquids after use.
- Do not use for bowel cleansing
- There are 3 teaspoons in 1 TABLEspoon
- Do not take more unless directed by a doctor. See Warnings
-
Other information
- each tablespoon contains: 1.6 g sodium
- saline laxatives increase retention of water in the intestines, promoting bowel movements
- this product generally produces a bowel movement in 30 minutes to 6 hours
- this product is sugar-free
- do not freeze
- store at 15 to 30°C (59 to 86°F)
- Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING.
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
ORAL SALINE LAXATIVE LEMON GINGER
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-044 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 1.4 g in 14.7868 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 6.2 g in 14.7868 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor LEMON, GINGER Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-044-01 1 in 1 CARTON 05/30/2012 1 45 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/30/2012 Labeler - Natureplex, LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-044)
