CLEARLAX POLYETHYLENE GLYCOL 3350 STRATEGIC SOURCING SERVICES LLC FDA Approved Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
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Route
ORAL
Applications
ANDA090812

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each dose) Polyethylene Glycol 3350 17 grams (cap filled to the indicated “17 GRAMS” line)
Inactive Ingredients
Inactive ingredients none Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Strengths
17 g
Treats Conditions
Uses Relieves Occasional Constipation Irregularity Generally Produces A Bowel Movement In 1 To 3 Days
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
UNII
G2M7P15E5P
Packaging

Package label 1

Package Descriptions
  • Package label 1

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.
Purpose

Purpose Osmotic Laxative

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 (800) 222-1222.

Storage & Handling

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.

Questions

Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST


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