SALINE LAXATIVE CHERRY LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form liquid

Saline Laxative Cherry by

Drug Labeling and Warnings

Saline Laxative Cherry by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc., 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 2.7 g/tablespoon.	Saline laxative
Monobasic sodium phosphate 7.2 g/tablespoon	Saline laxative

Use

• for relief of 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 right away: 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
• there are three teaspoons in one tablespoon
• do not take more unless directed by a doctor. See Warnings.

Ages (years)	Dosage	Maximum Dose
* SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD
12 & older	1 Tablespoon	2 or 3 Tablespoons*
10 & 11	1 Tablespoon*	1 Tablespoon*
5 to 9	1 ½ Teaspoons*	1 ½ Teaspoons*
Under 5	Do Not Use	Do Not Use

Other information

• Each Tablespoon contains: sodium 1.6 g
• 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

Cherry flavor, glycerin, purified water, saccharin sodium, sodium benzoate

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton

◀ FOR DIRECTIONS LIFT SIDE PANEL

NDC: 55910-339-24

Since 1903
Rexall®

Oral Saline
Laxative
Phosphate

For Relief of:

• Occasional
  Constipation

Cherry
Splash

1.5 FL OZ (45 mL)

INGREDIENTS AND APPEARANCE

SALINE LAXATIVE CHERRY   LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-339
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Phosphate, Dibasic (UNII: GR686LBA74) (Phosphate Ion - UNII:NK08V8K8HR, Sodium Cation - UNII:LYR4M0NH37)	Sodium Phosphate, Dibasic	2.7 g  in 45 mL
Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW) (Phosphate Ion - UNII:NK08V8K8HR, Sodium Cation - UNII:LYR4M0NH37)	Sodium Phosphate, Monobasic, Unspecified Form	7.2 g  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
CHERRY (UNII: BUC5I9595W)
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: 55910-339-24	1 in 1 CARTON	03/15/2016
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	03/15/2016

Labeler - Dolgencorp Inc. (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(55910-339)