MIGHTY LAX- polyethylene glycol 3350 powder

Mighty Lax by

Drug Labeling and Warnings

Mighty Lax by is a Otc medication manufactured, distributed, or labeled by Konsyl Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

MIGHTY LAX 
polyethylene glycol 3350 powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0224-1890
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	17 g  in 17 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0224-1890-01	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	10/01/2019

Labeler - Konsyl Pharmaceuticals, Inc. (102463866)