Polyethylene Glycol-3350
FDA Label NDC 40032-312

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Novel Laboratories, Inc. for the product Polyethylene Glycol-3350 (NDC 40032-312). 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 otc - active ingredient, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient (in each dose)..........................................Purpose

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

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

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

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 signs of a serious condition.

  • you get diarrhea

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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

  • Drug Facts (continued)

Otc - Pregnancy Or Breast Feeding

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

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.

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) then drink

    • use once a day

    • use no more than 7 days

    • children 16 years of age or under: ask a doctor

    • Other Information

      • store at 20° - 25°C (68°– 77°F)

      • tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive Ingredient

Inactive Ingredients                             none

Otc - Questions

Questions or comments?

1-800-FDA-1088 (1-800-332-1088) or www.fda.gov

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