Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID b320796c-39d5-4cbc-9a41-4aa42952f296
Route
ORAL
Published
Effective Date 2012-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Marketing Status
ANDA Active Since 2012-10-20

Description

Inactive Ingredients    none


Medication Information

Warnings and Precautions

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

Indications and Usage

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Dosage and 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





Description

Inactive Ingredients    none

Section 50565-1

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

Section 50566-9

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

Section 50569-3

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



Section 51727-6

Inactive Ingredients   none

Section 51945-4

Section 53413-1

Questions or comments?

1-800-403-9832

Section 53414-9

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

Section 55105-1

Purpose

Osmotic Laxative

Section 55106-9

Active Ingredient (in each dose)

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


Structured Label Content

Indications and Usage (34067-9)

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Dosage and Administration (34068-7)

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





Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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



Section 51727-6 (51727-6)

Inactive Ingredients   none

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-403-9832

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Osmotic Laxative

Section 55106-9 (55106-9)

Active Ingredient (in each dose)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)