POLYETHYLENE GLYCOL 3350 powder, for solution
Polyethylene Glycol 3350 by
Drug Labeling and Warnings
Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Polyethylene Glycol 3350, Powder for SOlution
- Active ingredient (in each dose) (CAN Only)
- Purpose
- Active ingredient (in each dose) (Packet Only)
- Purpose
- Use
-
WARNINGS
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 (CAN Only)
- 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
- use once a day
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- use no more than 7 days
- children 16 years of age or under: ask a doctor
Directions (Packet Only)
- 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
- Other Information
- INACTIVE INGREDIENT
- Questions or comments?
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packets
NDC: 59556-762-01
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN
- Dissolves in any beverage
- Sugar Free
10 PACKETS
NET WT 0.5 OZ (17g) EACH
10s carton
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packets
NDC: 59556-762-02
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN
- Dissolves in any beverage
- Sugar Free
24 PACKETS
NET WT 0.5 OZ (17g) EACH
24s carton
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 59556-762-00
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN
- Dissolves in any beverage
- Sugar Free
NET WT 0.5 OZ (17 g)
packet
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 59556-762-03
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Dissolves in any beverage
- Sugar Free
ONCE-DAILY
DOSES
NET WT 4.15 OZ (119 g)
119 g CAN - FRONT
119 g CAN - BACK
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 59556-762-04
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Dissoloves in any beverage
- Sugar Free
ONCE-DAILY
DOSES
NET WT 8.3 OZ (238 g)
238 G CAN - FRONT
238 G CAN - BACK
238 G CAN - BACK 1
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 59556-762-05
Original
Prescription
Strength
Polyethylene Glycol 3350
Powder for Solution
Osmotic Laxative
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
- Dissolves in any beverage
- Sugar Free
ONCE-DAILY
DOSES
NET WT 17.9 OZ (510 g)
510 g CAN - FRONT
510 g CAN - BACK
-
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 59556-762 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: 59556-762-04 238 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 2 NDC: 59556-762-03 119 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 3 NDC: 59556-762-05 510 g in 1 CAN; Type 0: Not a Combination Product 08/25/2016 4 NDC: 59556-762-02 24 in 1 CARTON 08/25/2016 4 NDC: 59556-762-00 17 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC: 59556-762-01 10 in 1 CARTON 08/25/2016 5 NDC: 59556-762-00 17 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203928 08/25/2016 Labeler - Strides Pharma Inc (078868278) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(59556-762) , MANUFACTURE(59556-762) , PACK(59556-762)
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