Label: POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution
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NDC Code(s):
69230-324-32,
69230-324-33,
69230-324-34,
69230-324-35, view more69230-324-36, 69230-324-37
- Packager: Camber Consumer Care Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH DOSE)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
(Bottle 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:• use once a day
• 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• do not combine with starch-based thickeners used for difficult swallowing
• ensure that the powder is fully dissolved before drinking
• do not drink if there are any clumps
• do not use more than 7 days
• children 16 years of age or under: ask a doctor
(Packet Only)
• do not take more than directed unless advised by your doctor
• adults and children 17 years of age and older:• use once a day
• stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink• do not combine with starch-based thickeners used for difficult swallowing
• ensure that the powder is fully dissolved before drinking
• do not drink if there are any clumps
• do not use more than 7 days
• children 16 years of age or under: ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69230-324 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:69230-324-32 7 in 1 CARTON 04/14/2021 1 17 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69230-324-33 10 in 1 CARTON 04/14/2021 2 17 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:69230-324-34 119 g in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2021 4 NDC:69230-324-35 238 g in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2021 5 NDC:69230-324-36 510 g in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2021 6 NDC:69230-324-37 14 in 1 CARTON 04/14/2021 6 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 ANDA214990 04/14/2021 Labeler - Camber Consumer Care Inc (079539968) Establishment Name Address ID/FEI Business Operations Annora Pharma Private Limited 650980746 manufacture(69230-324)