Comfortlax Powder, For Solution
FDA Label NDC 55319-056

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Stores, Llc for the product Comfortlax (NDC 55319-056). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Otc - 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

Otc - Ask Doctor/Pharmacist

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

Otc - 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

Otc - 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

Package Label-principal Display Panel (119 g Bottle Label)

Package Label-principal Display Panel (119 g Bottle Label)

* Please review the disclaimer below.