Label: SUNMARK CLEARLAX- polyethylene glycol 3350 powder, for solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 50090-1447-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 49348-893
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 27, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- Uses
-
Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol
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
-
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 (white section in cap)
- •
- adults and children 17 years of age and older:
- •
- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
- •
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- •
- use once a day
- •
- use no more than 7 days
- •
- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Polyethylene Glycol 3350
-
INGREDIENTS AND APPEARANCE
SUNMARK CLEARLAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1447(NDC:49348-893) 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 Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1447-0 238 g in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 10/07/2009 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-1447)