MiraLAX Orange Flavor POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC. FDA Approved Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
FunFoxMeds bottle
Route
ORAL
Applications
ANDA090685

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each dose) Polyethylene Glycol 3350 17 g (cap filled to line)
Inactive Ingredients
Inactive ingredients natural and artificial orange flavor sucralose
Strengths
17 g
Quantities
7 dose
Treats Conditions
Use Relieves Occasional Constipation Irregularity Generally Produces A Bowel Movement In 1 To 3 Days
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOTTLE
UPC
0041100600554
UNII
G2M7P15E5P
Packaging

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 PDP PDP MiraLAX Orange 7 dose Front Label

Package Descriptions
  • 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 PDP PDP MiraLAX Orange 7 dose Front Label

Overview

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

Indications & Usage

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

Dosage & Administration

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

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 of 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 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 If pregnant or breast-feeding, ask a health professional before use. 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).
Purpose

Purpose Osmotic Laxative

Do Not Use

Do not use if you have kidney disease, except under the advice and supervision of a doctor

When Using

When using this product you may have loose, watery, more frequent stools

Stop Use & Ask a Doctor

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

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).

Storage & Handling

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

Questions

Questions or comments? 1-800-MiraLAX (1-800-647-2529)


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