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Drug Facts
Miralax Orange Flavor Powder, For Solution
FDA Label NDC 11523-0122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Miralax Orange Flavor (NDC 11523-0122). 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 other, active ingredient (in each dose), purpose, use, allergy alert, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
Allergy Alert
Do not use if you are allergic to polyethylene glycol
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
Ask a doctor of pharmacist before use if you are taking a prescription drug
Otc - When Using
When using this product you may have loose, watery, more frequent stools
Stop Use And Ask A Doctor If
- you have rectal bleeding or you nausea, bloating or 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).
Directions (Bottle Only)
- 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:
- use once a day
- 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
- 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
- store at 20°-25°C (68°-77°F)
- tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Inactive Ingredients
natural and artificial orange flavor, sucralose
Questions Or Comments?
1-800-MiraLAX (1-800-647-2529)
Principal Display Panel - 7 Dose Bottle
MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative
Relieves Occasional Constipation/Irregularity
Softens Stool
Grit-Free Powder
Sugar-Free & Dye-Free
ORANGE FLAVOR
7 ONCE-DAILY DOSES
NET WT 4.1 OZ (119 g)
Bayer
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