MIGHTY LAX- polyethylene glycol 3350 powder 
Konsyl Pharmaceuticals, Inc.

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Mighty Lax

Drug Facts

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

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 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,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
  • fill to the indicated "17 GRAMS" line in cap which is marked to indicate the correct dose 17 grams
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • use once a day
  • use on more than 7 days
  • children 16 years or age or younger: ask a doctor
  • ensure the powder is fully dissolved before drinking
  • do not drink if there are any clumps

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?

1-410-822-5192 8:30 a.m. to 5 p.m. ET.

Package Labeling:

LabelLabel2Label3

MIGHTY LAX 
polyethylene glycol 3350 powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1890
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1890-01238 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/201910/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081210/01/201910/01/2021
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Revised: 12/2020
Document Id: b78c7b17-c001-41b4-e053-2995a90a04cb
Set id: 3e82de78-2f6f-47a6-b390-2be50b7a7a99
Version: 2
Effective Time: 20201228
 
Konsyl Pharmaceuticals, Inc.