Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID f283610e-b978-4b67-b78f-e43972232317
Route
ORAL
Published
Effective Date 2018-02-15
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 2015-01-05

Description

Inactive Ingredients    none

Indications and Usage

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

Purpose

Purpose Osmotic Laxative

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

How Supplied

Product: 50090-2526 NDC: 50090-2526-0 238 g in a BOTTLE


Medication Information

Indications and Usage

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Purpose

Purpose

Osmotic Laxative

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

How Supplied

Product: 50090-2526

NDC: 50090-2526-0 238 g in a BOTTLE

Description

Inactive Ingredients    none

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

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

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

Questions?

Questions or comments?

1-800-645-2158

Active Ingredient

Active Ingredient (in each dose)

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

Pregnancy Warning

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

Inactive Ingredients

Inactive Ingredients   none

Polyethylene Glycol 3350
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.


Structured Label Content

Purpose

Purpose

Osmotic Laxative

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

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

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

Questions?

Questions or comments?

1-800-645-2158

How Supplied (HOW SUPPLIED)

Product: 50090-2526

NDC: 50090-2526-0 238 g in a BOTTLE

Active Ingredient

Active Ingredient (in each dose)

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

Pregnancy Warning

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

Inactive Ingredients

Inactive Ingredients   none

Indications and Usage

Use

-relieves occasional constipation (irregularity)

-generally produces a bowel movement in 1 to 3 days

Polyethylene Glycol 3350 (POLYETHYLENE GLYCOL 3350)
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

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.


Advanced Ingredient Data


Raw Label Data

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