COMFORTLAX- polyethylene glycol 3350 powder, for solution

COMFORTLAX by

Drug Labeling and Warnings

COMFORTLAX by is a Otc medication manufactured, distributed, or labeled by Family Dollar Stores, LLC, Aurohealth LLC, Aurobindo Pharma Limited, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams 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

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug

WHEN USING

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

PREGNANCY OR BREAST FEEDING

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 (1-800-222-1222) right away.

Directions

• do not take more than directed unless advised by your doctor
• this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
• adults and children 17 years of age and older:
  • use once a day
  • fill to the indicated 17 grams line on cup 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
  • 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

Other information

• store at 20° to 25°C (68° to 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?

call 1-855-274-4122

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PKWY
CHESAPEAKE, VA 23320 USA

MADE IN INDIA

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label

FAMILY
WellnessTM

COMPARE TO THE ACTIVE
INGREDIENT OF MIRALAX®*

COMFORTLAX®                                                UNFLAVORED
Polyethylene Glycol 3350                                         POWDER -
Powder for Oral Solution                                        GRIT FREE
Osmotic Laxative
Relieves Occasional Constipation/Irregularity
Softens Stool

7 ONCE-DAILY DOSES
NET WT 4.1 OZ (119 g)                               NDC: 55319-056-24

INGREDIENTS AND APPEARANCE

COMFORTLAX 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-056
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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-056-24	119 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	09/04/2024
2	NDC: 55319-056-33	238 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	09/04/2024
3	NDC: 55319-056-27	510 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	09/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209017	09/04/2024

Labeler - Family Dollar Stores, LLC (024472631)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(55319-056) , MANUFACTURE(55319-056)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(55319-056) , MANUFACTURE(55319-056)