Ez2go
FDA Label NDC 76470-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valley Medical Products,llc for the product Ez2go (NDC 76470-006). 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 inactive ingredient, otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Inactive Ingredient

Inactive Ingredients   none

Otc - Active Ingredient

Active Ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Otc - Purpose

Purpose

Osmotic Laxative

Warnings

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

When using this product, you may have loose, watery, more frequent bowel movements

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


Otc - Stop Use

Stop use and ask a doctor if

- you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse.These may be sogns of a serious condition.

- you get diarrhea

- you need to use a laxative for longer than 1 week

- side effects occur

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER  right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Dosage & Administration

Directions

-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

-adults and children 17 years of age and older:

    -fill to top of line 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) and then drink

    -use once a day

    -use no more than 7 days

-Children 16 years of age or under:  ask a doctor



Otc - Questions

Questions or comments?

1-800-403-9832

Indications & Usage

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

* Please review the disclaimer below.