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  5. Label Information: Natura-lax

FDA Label for Natura-lax

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH DOSE)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. FOR SERIOUS ADVERSE EVENTS CALL:
    10. PACKAGE LABEL

Natura-lax Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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.

Active Ingredient (In Each Dose)



Polyethylene Glycol 3350, 17g (cap filled to the top)


Purpose



Laxative


Uses



  • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 1 to 3 days

Warnings



Allergy alert: Do not use if you are allergic to polyethylene glycol


Do not use if you have kidney disease, except under the advice and supervision of a doctor


Ask a doctor before use if you have


  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

    • Ask a doctor or pharmacist before use if you are taking a prescription drug

    When using this product     you may have loose, watery, more frequent stools


    Stop use and ask a doctor if

    • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
    • you get diarrhea
    • you need to use a laxative for longer than 1 week

      • 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 right away.


Directions



  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • fill to 17 grams line in cap for the correct dose
      • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
        • use once daily
          • use no more than 7 days
          • children 16 years of age or younger: ask a doctor

Other Information



  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive Ingredients



none


For Serious Adverse Events Call:



1-888-710-0006



Package Label



NDC 63868-002-14

Quality Choice

compare to the active ingredient in miralax

original  prescription strength

Natura-LAX

Osmotic Laxative

polyethylene glycol 3350

powder for solution

Dissolves in Any Beverage

relieves occasional constipation (irregularity)

softens stool

14 once daily doses

net wt 8.3 oz (238 g)




* Please review the disclaimer below.