HEALTHYLAX- polyethylene glycol 3350 powder, for solution

healthylax by

Drug Labeling and Warnings

healthylax by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350 NF - 17 g

Purpose

Laxative

Use

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 2 to 4 days

Warnings

Allergy alert

Do not use if you are allergic to polyethylene glycol

Ask a doctor before use if you have:

• nausea, vomiting, abdominal pain or distention.
• suspected 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 unusual cramps, bloating or diarrhea.
• you get hives or skin rashes.
• you need to use a laxative for longer than 2 weeks.

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

Keep this and all medications 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
• Stir and dissolve one packet of powder (17 g) in a glass (4 to 8 oz.) of water, juice, soda, coffee, or tea until completely dissolved.
• Drink the solution.
• Daily dose is 17 grams per day or as directed by a healthcare professional.
• Treatment for 2 to 4 days may be required to produce a bowel movement.
• Use for 2 weeks or less.
• Should not be used by children.

Other information

• Store at 20°-25°C (68°-77°F); excursions permitted to 15º - 30ºC (59º - 86ºF). [See USP Controlled Room Temperature]
• Tamper-evident: do not use if foil is open or broken.

Inactive ingredients

none

Questions or comments?

1-800-707-4621 or www.americanhealthpackaging.com

PRINCIPAL DISPLAY PANEL - 17g Packet Carton

NDC: 68084-430-98

healthylax
Polyethylene Glycol 3350 NF,
Powder for Oral Laxative Solution

• Relieves Occasional Constipation
• Softens Stool
• 14 Daily Doses

NET WT. 14 - 17 g SACHETS
8.4 Oz. (238g)

Healthylax Pouch - 17 g

NDC: 68084-430-99

healthylax
POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

• Relieves Occasional Constipation
• Softens Stool
• 1 Daily Dose

NET WT. 17g

INGREDIENTS AND APPEARANCE

HEALTHYLAX 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68084-430(NDC:0722-7116)
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

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68084-430-98	14 in 1 CARTON	09/02/2010	09/30/2020
1	NDC: 68084-430-99	17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	09/01/2010	09/30/2020

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-430)