Label: ORAL SALINE LAXATIVE- dibasic sodium phosphate, monobasic sodium phosphate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0126-12 - Packager: Walgreen Co
- 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 December 17, 2013
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- Official Label (Printer Friendly)
- Active ingredient (in each tablespoon)
- Purpose
- Use
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Warnings
Dosage warning
Taking more than the recommended dose in 24 hours can be harmful.
Do not use
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- if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities
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- in children under 5 years of age
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- for bowel cleansing
Ask a doctor before use if you have
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- abdominal pain, nausea, or vomiting
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- kidney disease
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- heart problems
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- a sudden change in bowel habits lasting more than 2 weeks
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- already used a laxative for more than a week
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- a dehydration condition
Ask a doctor or pharmacist before use if you are
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- on a sodium restricted diet
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- under a doctor’s care for any medical condition
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- taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if you
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- have any rectal bleeding
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- do not have a bowel movement within 6 hours
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- have any symptoms that your body is losing more fluid than you are drinking
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- have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting.
- These symptoms may indicate a serious condition.
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Directions
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- use as a laxative for relief of occasional constipation
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- dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use.
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- Do not use for bowel cleansing.
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- Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon.
Ages (Years)
Dosage
Maximum Dose
12 & Older
3 Teaspoons
6 or 9 Teaspoons*
10 & 11
3 Teaspoons*
3 Teaspoons*
5 to 9
1 1/2 Teaspoons*
1 1/2 Teaspoons*
under 5
Do Not Use
Do Not Use
- *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD
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Other information
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- Each Teaspoon contains: sodium 556 mg
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- Saline laxatives increase retention of water in the intestine, promoting bowel movements.
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- this product generally produces a bowel movement in 30 minutes to 6 hours
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- this product is sugar free
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- do not freeze
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- store at room temperature
TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use.
- Inactive ingredients
- Questions
- Package/Label Principal Display Panel
- Drug Facts 1
- Drug Facts 2
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INGREDIENTS AND APPEARANCE
ORAL SALINE LAXATIVE
dibasic sodium phosphate, monobasic sodium phosphate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0126 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC .9 g in 15 mL SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC 2.4 g in 15 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0126-12 1 in 1 CARTON 1 45 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/05/2012 Labeler - Walgreen Co (008965063)
