ORAL SALINE LAXATIVE GINGER LEMON- dibasic sodium phosphate, monobasic sodium phosphate liquid

Oral Saline Laxative by

Drug Labeling and Warnings

Oral Saline Laxative by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablespoon)	Purpose
Dibasic Sodium Phosphate 1.4 g/tablespoon	Saline laxative
Monobasic Sodium Phosphate 6.2 g/tablespoon	Saline laxative

Use

Relieves occasional constipation

Warnings

Dosage warning

Taking more than the recommended dose in 24 hour can be harmful.

Do not use

• if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities
• in children under 5 years old
• for bowel cleansing

Ask a doctor before use if you have

• abdominal pain, nausea, or vomiting
• kidney disease
• heart problems
• a sudden change in bowel habits lasting more than 2 weeks
• already used a laxative for more than a week
• dehydration

Ask a doctor or pharmacist before use if you are

• on a sodium restricted diet
• under a doctor's care for any medical condition
• taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you

• have any rectal bleeding
• do not have a bowel movement within 6 hours
• have any symptoms that your body is losing more fluid than you are drinking
• have symptoms of dehydration including
  • thirstiness
  • dizziness
  • urinating less often than normal
  • vomiting

These symptoms may indicate a serious condition.

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 immediately: 800-222-1222.

Directions

• Use as a laxative for relief of occasional constipation
• dilute dose in the table below with one glass (8 fl. oz.) of cool water. Drink, then follow with at least one additional glass (8 fl. oz.) of cool water. There is significant loss of liquid when using this product. To prevent dehydration, drink plenty of clear liquid after use.
• Do not use for bowel cleansing.
• Do not take more unless directed by a doctor. See Warnings. There are three teaspoons in one tablespoon.

Ages (years)	Dosage	Maximum Dose
* SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD
12 & older	3 Teaspoons	6 or 9 Teaspoons*
10 & 11	3 Teaspoons*	3 Teaspoons*
5 to 9	1 ½ Teaspoons*	1 ½ Teaspoons*
Under 5	Do Not Use	Do Not Use

Other information

• Each Teaspoon contains: sodium 549 mg
• Saline laxatives increase retention of water in the intestines, promoting bowel movements.
• this product generally produces a bowel movement in 30 minutes to 6 hours
• this product is sugar free
• do not freeze
• store at 15 to 30°C (59 to 86°F)

Inactive ingredients

glycerin, lemon and ginger flavor, purified water, saccharin sodium, sodium benzoate

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton

FOR DIRECTIONS LIFT SIDE PANEL

CVS
Health™

NDC: 59779-111-12

Phosphate
Oral Saline
Laxative

For relief of occasional
constipation

Ginger Lemon Flavor

1.5 FL OZ (45 mL)

INGREDIENTS AND APPEARANCE

ORAL SALINE LAXATIVE  GINGER LEMON
dibasic sodium phosphate, monobasic sodium phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	1.4 g  in 14.7868 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	6.2 g  in 14.7868 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-111-12	1 in 1 CARTON	08/31/2012
1		45 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/31/2012

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(59779-111)