LAXATIVE- polyethylene glycol 3350 powder, for solution

LAXATIVE by

Drug Labeling and Warnings

LAXATIVE by is a Otc medication manufactured, distributed, or labeled by FRED'S INC., Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)

Purpose

Laxative

Uses

• 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

• do not take more than directed unless advised by your doctor
• the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
• adults and children 17 years of age and older:
  • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
• 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 younger: ask a doctor

Other information

• store at 20° - 25°C (68° - 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

For serious adverse events call:

1-888-710-0006

Package label

fred's Pharmacy

NDC: 55315-369-31

original prescription strength

Laxative

polyethylene glycol 3350
Softens stool
powder for solution/ osmotic laxative

relieves occasional constipation (irregularity)

compare to the active ingredient in miralax
30 once daily doses
net wt 17.9 oz (510 g)

INGREDIENTS AND APPEARANCE

LAXATIVE 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-369
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: 55315-369-31	510 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	09/01/2015	03/01/2021

Labeler - FRED'S INC. (005866116)

Registrant - Geri-Care Pharmaceutical Corp (611196254)