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  5. Label Information: Polyethylene Glycol 3350

FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SACHET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OF PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF THE REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 14UD
    16. PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 100 UD
    17. PACKAGE/LABEL DISPLAY PANEL – SACHET – 17 G

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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 Sachet)



Polyethylene Glycol 3350, NF 17g


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 Of 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.


Keep Out Of The 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
  • adults and children 17 years of age and older:
  • stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature)
  • drink the solution.
  • use once a day
  • use no more than 7 days
  • children 16 years of age or under: ask a doctor

Other Information



  • store at 20° - 25°C (68° - 77°F)
  • do not use if foil is open or broken.

Inactive Ingredients



none


Questions Or Comments?



1-800-707-4621 or www.americanhealthpackaging.com

© 2019 & Distributed by
American Health Packaging
Columbus, Ohio 43217 USA

All rights reserved.

1037831/1037832


Package/Label Display Panel - Carton - 17 G - 14Ud



17 g Healthylax Carton (14 Sachet) - Carton 14ct HealthyLax 0219

17 g Healthylax Carton (14 Sachet) - Carton 14ct HealthyLax 0219

NDC 60687- 431-98

healthylax ®
POLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

14 SACHETS
Net Wt. 0.6 OZ (17g) EACH

Distributed by American Health Packaging, Columbus, Ohio 43217


Package/Label Display Panel – Sachet – 17 G



17 g HealthyLax Sachet - Sachet HealthyLax 0219

17 g HealthyLax Sachet - Sachet HealthyLax 0219

NDC 60687- 431-99

healthylax ®
POLYETHYLENE GLYCOL 3350 NF
Powder for Oral Laxative Solution

Net Wt. 0.6 OZ (17g)

Distributed by American Health Packaging, Columbus, Ohio 43217


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