POLYETHYLENE GLYCOL 3350- 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 Camber Consumer Care Inc, Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH DOSE)

(Bottle Only)            


Polyethylene Glycol 3350, 17 g (cap filled to line)


(Packet Only)            


Polyethylene Glycol 3350, 17 g 

PURPOSE

Osmotic Laxative

USE

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

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. 

KEEP OUT OF REACH OF CHILDREN

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

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

store at 20° to 25°C (68° to 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

QUESTIONS OR COMMENTS?

call 1-888-588-1418.

PRINCIPAL DISPLAY PANEL

Polyethylene glycol 3350 powder for oral solution bottle label

 

Polyethylene glycol 3350 powder for oral solution carton label

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350  
polyethylene glycol 3350 powder, for solution

Product 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)