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  5. Label Information: Oral Saline Laxative Cherry Laxative

FDA Label for Oral Saline Laxative Cherry Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USE
    4. DOSAGE WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF YOU
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 45 ML BOTTLE CARTON

Oral Saline Laxative Cherry Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Natureplex, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each tablespoon)Purpose
Dibasic Sodium Phosphate 1.4 g/tablespoonSaline laxative
Monobasic Sodium Phosphate 6.2 g/tablespoonSaline laxative

Use



Relieves occasional constipation


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 symptoms of dehydration including
    • thirstiness
    • dizziness
    • urinating less often than normal
    • vomiting

      • These symptoms may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


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)DosageMaximum Dose
    12 & older3 Teaspoons6 or 9 Teaspoons

    SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD

    10 & 113 Teaspoons3 Teaspoons
    5 to 91 ½ Teaspoons1 ½ Teaspoons
    Under 5Do Not UseDo Not Use

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 to 30°C (59 to 86°F)

Inactive Ingredients



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


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 45 Ml Bottle Carton



◀ FOR DIRECTIONS LIFT SIDE PANEL

Natureplex™

ORAL SALINE
NDC 67234-041-01

Laxative
Phosphate
For Relief Of
Occasional
Constipation

Cherry
Splash

1.5 Fl Oz (45 mL)

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton - laxative 01

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton - laxative 01


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