FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

OTHER
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE
USE
ALLERGY ALERT
OTC - DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENT
OTC - QUESTIONS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Gericare Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Otc - Active Ingredient Section

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated line)

Otc - Purpose

Osmotic Laxative

Use

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

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 of 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.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 (white section in cap)
adults and children 17 years of age and older:
- fill to top of white section 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° 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 Ingredient

none

Otc - Questions

Questions or comments?

1-800-540-3765

Manufactured by

Gericare Pharmaceuticals

1650 63rd Street, Brooklyn, NY 11204

Product of India

Issued: 10/2018

Package Label.Principal Display Panel

NDC 57896-490-30

Original

Prescription

Strength

Polyethylene Glycol 3350

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