Label: CLEARLAX- polyethylene glycol powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-566-10 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0113-0306
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 12, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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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.
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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
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
CLEARLAX
polyethylene glycol powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-566(NDC:0113-0306) Route of Administration TOPICAL 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-566-10 10 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 10/07/2009 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK