Label: ORAL SALINE LAXATIVE- dibasic sodium phosphate, monobasic sodium phosphate liquid

  • 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 January 3, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablespoon) Purpose
    Dibasic sodium phosphate 1.4 g Saline laxative
    Monobasic sodium phosphate 6.2 g Saline laxative
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  • Use

    • for relief of occasional constipation
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  • Warnings

    Dosage warning

    Taking more than the recommended dose in 24 hour can be harmful.

    Do not use

    • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities
    • in children under 5 years old
    • for bowel cleansing

    Ask a doctor before use if you have

    • abdominal pain, nausea, or vomiting
    • kidney disease
    • heart problems
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than a week
    • dehydration

    Ask a doctor or pharmacist before use if you are

    • on a sodium restricted diet
    • under a doctor's care for any medical condition
    • 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

    • have any rectal bleeding
    • do not have a bowel movement within 6 hours
    • have any symptoms that your body is losing more fluid than you are drinking
    • have early symptoms of dehydration including
      • thirstiness
      • dizziness
      • urinating less often than normal
      • vomiting

    These symptoms may indicate a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately 1-800-222-1222.

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  • Directions

    • 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 liquid when using this product. To prevent dehydration, drink plenty of clear liquid after use.
    • Do not use for bowel cleansing.
    • Do not take more unless directed by a doctor. See Warnings. There are three teaspoons in one tablespoon.
    Ages (years) Dosage Maximum Dose
    *
    SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD
    12 & older 3 Teaspoons 6 or 9 Teaspoons*
    10 & 11 3 Teaspoons* 3 Teaspoons*
    5 to 9 1 ½ Teaspoons* 1 ½ Teaspoons*
    Under 5 Do Not Use Do Not Use
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  • Other information

    • Each Teaspoon contains: sodium 549 mg
    • 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 - 30°C (59 - 86F°)
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  • Inactive ingredients

    Cherry flavor, glycerin, purified water, saccharin sodium, sodium benzoate

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  • Questions?

    1-866-323-0107

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

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  • PRINCIPAL DISPLAY PANEL - 44 mL Bottle Carton

    NDC 0363-0127-12

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDED

    SUGAR FREE
    SINGLE DOSE

    Oral Saline
    Laxative
    Phosphate

    • For the relief
      of occasional constipation

    SUGAR
    FREE

    1.5 FL OZ
    (44 mL)

    CHERRY
    FLAVOR

    PRINCIPAL DISPLAY PANEL - 44 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ORAL SALINE LAXATIVE 
    dibasic sodium phosphate, monobasic sodium phosphate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0127
    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 1.4 g  in 15 mL
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 6.2 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:0363-0127-12 1 in 1 CARTON 10/05/2012
    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 10/05/2012
    Labeler - Walgreen Co (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex LLC 062808196 MANUFACTURE(0363-0127)
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