NDC | 55319-306-01, 55319-306-02, 55319-306-17 |
Set ID | 3a52cc90-2ea4-4676-a7c9-26b93ecb1a64 |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Dollar Services Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA090685 |
- Active ingredient (in each dose)
- Purpose
- Use
-
Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol
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
-
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:
- •
- 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
- •
- ensure that the powder is fully dissolved before drinking
- •
- do not drink if there are any clumps
- •
- use once a day
- •
- use no more than 7 days
- •
- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN MIRALAX®
Laxative Powder
Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative
Relieves Occasional Constipation/Irregularity
Softens Stool
Unflavored Powder • Grit Free
14 Once-Daily Doses
NET WT 8.3 OZ (238 g)
100% SATISFACTION GUARANTEED OR YOUR MONEY BACK
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS LAXATIVE
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-306 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-306-01 119 g in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2011 03/23/2015 2 NDC:55319-306-02 238 g in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2012 3 NDC:55319-306-17 289 g in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 06/21/2011 Labeler - Family Dollar Services Inc (024472631)