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healthylax

American Health Packaging


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g

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 you nausea, bloating or 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 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
  • adults and children 17 years of age and older:
    • stir and dissolve one packet of powder (17 g) 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

healthylax Other information

  • store at 20°-25°C (68°-77°F)
  • 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

14 Pouches

NDC 68084-430-98

healtyax  
Polyethylene Glycol 3350 NF,

Powder for Oral Laxative Solution  

  • Relieves Occasional Constipation
  • Softens Stool
  • 14 Daily Doses

14 POUCHES

EACH PACKET NET WT 0.5 OZ (17g)

healthylax

healthylax

Polyethylene Glycol 3350 POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68084-430(NDC:0722-7116)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 17 g

Product Characteristics

Color
WHITE (Colorless upon dissolution)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-430-99 17 in 1 POUCH
2 NDC:68084-430-98 14 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090812 2011-02-01


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Be sure to consult your doctor before taking any medication!
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