Label: CLEARLAX- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 70677-1068-1, 70677-1068-2
- Packager: STRATEGIC SOURCING SERVICES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 29, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- Uses
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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.
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Directions
- do not take more than directed unless advised by your doctor
- the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
- adults and children 17 years of age and older:
- use once a day
- fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use more than 7 days
- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Package label
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INGREDIENTS AND APPEARANCE
CLEARLAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1068 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:70677-1068-1 238 g in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2023 2 NDC:70677-1068-2 510 g in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090812 08/01/2023 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Registrant - Geri-Care Pharmaceutical Corp (611196254)