SPL v1
SPL
SPL Set ID b4a571c7-230a-4955-875e-112cbe1f5596
Route
ORAL
Published
Effective Date 2018-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2018-08-07

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated "17 GRAMS" line)

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated "17 GRAMS" line)

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.
Directions
  • do not take more than directed unless advised by your doctor
  • the bottle cap is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
  • adults and children 17 years of age and older:
  • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
  • stir and dissolve 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 younger: ask a doctor

Package Label

Other Information
  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive Ingredients

none

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16 TH PLACE 

MIAMI, FL 33179

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated "17 GRAMS" line)

For Serious Adverse Events Call:

1-888-710-0006


Structured Label Content

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

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.

Purpose

Laxative

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.
Directions
  • do not take more than directed unless advised by your doctor
  • the bottle cap is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
  • adults and children 17 years of age and older:
  • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
  • stir and dissolve 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 younger: ask a doctor

Package Label (Package label)

Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.

Inactive Ingredients (Inactive ingredients)

none

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16 TH PLACE 

MIAMI, FL 33179

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated "17 GRAMS" line)

For Serious Adverse Events Call: (For serious adverse events call:)

1-888-710-0006


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)