POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution
Camber Consumer Care Inc

----------

Polyethylene Glycol 3350 Powder for Oral Solution, 17 g

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:
   • 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

(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
  • 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

• 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 carton label

polyethylene

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214990	04/14/2021

Labeler - Camber Consumer Care Inc (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Annora Pharma Private Limited		650980746	analysis(69230-324) , manufacture(69230-324)

Revised: 1/2023

Document Id: f31369e5-4265-08a6-e053-2995a90a3d05

Set id: b321a7f5-f80b-4a51-9fd9-2c21fc1cae9b

Version: 4

Effective Time: 20230125

Camber Consumer Care Inc