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- View NDC Code(s)NEW!
- NDC Code(s): 11523-4357-1, 11523-4357-2, 11523-4357-3, 11523-4357-5, view more
11523-7234-1, 11523-7234-2, 11523-7234-3, 11523-7234-4, 11523-7234-5, 11523-7234-6, 11523-7234-9, 11523-7268-3, 11523-7268-4, 11523-7268-7, 11523-7268-8, 11523-7268-9, 11523-7341-1, 11523-7341-2
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
View All Sections
- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each dose) (Bottle Only)
Polyethylene Glycol 3350, 17 g (cap filled to line)
- Purpose
Osmotic Laxative
- Active ingredient (in each dose) (Packet Only)
Polyethylene Glycol 3350, 17 g
- Purpose
Osmotic Laxative
- Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
- 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
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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 no more than 7 days
- children 16 years of age or under: ask a doctor
- Directions (Packet Only)
- do not take more than directed unless advised by your doctor
- adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
- Inactive ingredients
none
- Questions or comments?
1-800-MiraLAX (1-800-647-2529)
- PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton
20
Single Doses
#1 DOCTOR RECOMMENDED BRAND
MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative
Mix-In Pax ®
- Relieves Occasional Constipation/Irregularity
- Softens Stool
20
ONCE-DAILY DOSES
Bayer
Unflavored Powder Dissolves in ANY Beverage!
UNFLAVORED
POWDER
GRIT FREE20 PACKETS
NET WT 0.5 OZ
(17g) EACH
- PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton
10
Single Doses
#1 DOCTOR RECOMMENDED BRAND
MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic LaxativeMix-In Pax ®
- Relieves Occasional Constipation/Irregularity
- Softens Stool
10
ONCE-DAILY DOSES
Bayer
Unflavored Powder Dissolves in ANY Beverage!
UNFLAVORED
POWDER
GRIT FREE10 PACKETS
NET WT 0.5 OZ(17g) EACH
- PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label
Easy to Pour Bottle
#1 DOCTOR RECOMMENDED BRAND
MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative
UNFLAVORED
POWDER
GRIT FREE
- Relieves Occasional Constipation/Irregularity
- Softens Stool
Bayer
30 ONCE-DAILY DOSES
NET WT 17.9 OZ (510 g)
- PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label
Twin Pack!
2 x 34 Doses
Easy to Pour Bottle
MiraLAX ®
Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative
#1 DOCTOR RECOMMENDED BRAND
- Relieves Occasional Constipation/Irregularity
- Softens Stool
UNFLAVORED
POWDER
GRIT FREE
Bayer
34 ONCE-DAILY DOSES
NET WT 20.4 OZ (578 g)
- INGREDIENTS AND APPEARANCE
MIRALAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17g in17g Product Characteristics Color white (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7268-3 10 in 1 CARTON 02/01/2007 1 17 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:11523-7268-8 24 in 1 CARTON 02/01/2007 2 17 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:11523-7268-7 5 in 1 CARTON 02/01/2007 01/01/2015 3 17 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:11523-7268-4 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007 5 NDC:11523-7268-9 20 in 1 CARTON 02/01/2007 5 17 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 02/01/2007 MIRALAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7234 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17g in17g Product Characteristics Color white (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7234-1 17 g in 1 PACKET; Type 0: Not a Combination Product 02/01/2007 2 NDC:11523-7234-2 119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007 3 NDC:11523-7234-3 238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007 4 NDC:11523-7234-4 510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007 5 NDC:11523-7234-5 12 in 1 CARTON 02/01/2007 01/01/2012 5 17 g in 1 PACKET; Type 0: Not a Combination Product 6 NDC:11523-7234-6 17 g in 1 PACKET; Type 0: Not a Combination Product 02/01/2007 7 NDC:11523-7234-9 2 in 1 CELLO PACK 02/01/2007 01/01/2014 7 510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 02/01/2007 MIRALAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7341 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17g in17g Product Characteristics Color white (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7341-1 612 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2007 2 NDC:11523-7341-2 3 in 1 CARTON 02/01/2007 2 17 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 02/01/2007 MIRALAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4357 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17g in17g Product Characteristics Color white (colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-4357-1 2 in 1 PACKAGE, COMBINATION 02/01/2007 01/01/2018 1 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:11523-4357-3 2 in 1 PACKAGE, COMBINATION 02/01/2007 2 578 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:11523-4357-5 24 in 1 CARTON 05/01/2018 3 17 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:11523-4357-2 2 in 1 CARTON 02/01/2007 4 20 in 1 CARTON 4 17 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 02/01/2007 Labeler -Bayer HealthCare LLC.(112117283)
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
MIRALAX- polyethylene glycol 3350 powder, for solution
Number of versions: 17
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Dec 5, 2023 | 21 (current) | download |
| Jul 7, 2023 | 20 | download |
| Feb 14, 2022 | 19 | download |
| Nov 5, 2020 | 18 | download |
| Jun 25, 2020 | 17 | download |
| May 13, 2019 | 16 | download |
| Dec 11, 2018 | 15 | download |
| Oct 11, 2018 | 14 | download |
| Jun 22, 2018 | 13 | download |
| May 4, 2017 | 12 | download |
| Oct 27, 2016 | 11 | download |
| Jun 2, 2016 | 10 | download |
| Apr 16, 2014 | 9 | download |
| Oct 22, 2013 | 8 | download |
| Feb 14, 2013 | 5 | download |
| Dec 13, 2011 | 3 | download |
| Aug 5, 2010 | 2 | download |
RxNorm
MIRALAX- polyethylene glycol 3350 powder, for solution
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | PSN |
| 2 | 876193 | polyethylene glycol 3350 17000 MG Powder for Oral Solution | SCD |
| 3 | 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | SY |
| 4 | 876195 | MiraLAX 17 GM Powder for Oral Solution | PSN |
| 5 | 876195 | polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax] | SBD |
| 6 | 876195 | Miralax 17 GM Powder for Oral Solution | SY |
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MIRALAX- polyethylene glycol 3350 powder, for solution
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NDC Codes
MIRALAX- polyethylene glycol 3350 powder, for solution
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 11523-4357-1 |
| 2 | 11523-4357-2 |
| 3 | 11523-4357-3 |
| 4 | 11523-4357-5 |
| 5 | 11523-7234-1 |
| 6 | 11523-7234-2 |
| 7 | 11523-7234-3 |
| 8 | 11523-7234-4 |
| 9 | 11523-7234-5 |
| 10 | 11523-7234-6 |
| 11 | 11523-7234-9 |
| 12 | 11523-7268-3 |
| 13 | 11523-7268-4 |
| 14 | 11523-7268-7 |
| 15 | 11523-7268-8 |
| 16 | 11523-7268-9 |
| 17 | 11523-7341-1 |
| 18 | 11523-7341-2 |
