Label: POLYETHYLENE GLYCOL 3350 powder, for solution
- NDC Code(s): 60687-431-92, 60687-431-98, 60687-431-99
- Packager: American Health Packaging
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 4, 2022
If you are a consumer or patient please visit this version.
- Active Ingredient (in each sachet)
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
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
- Keep out of the reach of children.
- 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
Questions or comments?
1-800-707-4621 or www.americanhealthpackaging.com
© 2019 & Distributed by
American Health Packaging
Columbus, Ohio 43217 USA
All rights reserved.
- Package/Label Display Panel - Carton - 17 g - 14UD
- PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 100 UD
- Package/Label Display Panel – Sachet – 17 g
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-431 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g in 17 g Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-431-98 14 in 1 CARTON 05/29/2019 1 NDC:60687-431-99 17 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:60687-431-92 100 in 1 CARTON 02/26/2020 2 NDC:60687-431-99 17 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203928 05/29/2019 Labeler - American Health Packaging (929561009)