MIRALAX ORANGE FLAVOR- polyethylene glycol 3350 powder, for solution 
Bayer HealthCare LLC.

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MiraLAX ® Orange Flavor

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Use

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).

Directions (Bottle Only)

Other information

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

MiraLAX Orange 7 dose Front LabelMiraLAX Orange 7 dose Back Label

MIRALAX ORANGE FLAVOR 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Colorwhite (White or almost white solid with a waxy or paraffin-like appearance) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0122-2119 g in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
2NDC:11523-0122-1238 g in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068509/15/2023
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2023
Document Id: 0a5b0131-5a12-60bb-e063-6394a90af922
Set id: 0a5b2121-928f-8f49-e063-6394a90a8aaf
Version: 1
Effective Time: 20231003
 
Bayer HealthCare LLC.