SMOOTHLAX- polyethylene glycol 3350 powder, for solution

smoothlax by

Drug Labeling and Warnings

smoothlax by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

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

Purpose

Osmotic 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

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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:
• use once a day
• 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
• do not combine with starch-based thickeners used for difficulty swallowing
• ensure that the powder is fully dissolved before drinking
• do not drink if there are any clumps
• do not use 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 ingredients

natural and artificial orange flavor, sucralose

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in MiraLAX®

Orange Flavor

SmoothLAX®

POLYETHYLENE GLYCOL 3350

POWDER FOR SOLUTION, OSMOTIC LAXATIVE

Grit Free

Sugar Free

Dye Free

Relieves occasional constipation (irregularity)

Softens stool

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Orange flavor

INGREDIENTS AND APPEARANCE

SMOOTHLAX 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1323
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1323-03	510 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2023
2	NDC: 0363-1323-02	238 g in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090685	02/10/2023

Labeler - Walgreen Company (008965063)