Label: POLYETHYLENE GLYCOL powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 63940-762-03, 63940-762-04, 63940-762-05 - Packager: Harmon Stores, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 4, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose)
- Purpose
- Use
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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 of pharmacist before use if you are taking a prescription drug
- When using this product you may have loose, watery, more frequent stools
- Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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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
- 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?
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
NET WT 4.15 OZ (119 g)
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
NET WT 8.3 OZ (238 g)
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Polyethylene Glycol 3350
Powder for Solution
OSMOTIC LAXATIVE
Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.
- Relieves Occasional Constipation (Irregularity)
- Softens Stool
- Dissolves in any beverage
- Sugar Free
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN
NET WT 17.9 OZ (510 g)
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL
polyethylene glycol powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-762 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:63940-762-03 119 g in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2016 2 NDC:63940-762-04 238 g in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2016 3 NDC:63940-762-05 510 g in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203928 08/24/2016 Labeler - Harmon Stores, Inc (804085293) Registrant - Strides Shasun Limited (918513263) Establishment Name Address ID/FEI Business Operations Strides Shasun Limited 918513263 ANALYSIS(63940-762) , MANUFACTURE(63940-762) , PACK(63940-762)