Active Ingredient
Polyethylene Glycol
Clearlax
FDA Label NDC 21695-566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Clearlax (NDC 21695-566). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Use(s)
• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days
Uses
Use(s)
• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days
Warnings
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
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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 packet of powder (17 g) 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
• 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
• store at 20°-25°C (68°-77°F)
• tamper-evident: do not use if printed foil pouch is open or broken (Pouch Carton Only)
• tamper-evident: do not use if printed foil seal under cap is missing, open or broken (Label Only)
Inactive Ingredients
Inactive ingredients
none
Package/Label Principal Display Panel
Clearlax (polyethylene Glycol) 17gm (Da73cc74 908f 4497 8770 6c1d774f5ce2 01)
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