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

ORAL SALINE LAXATIVE CHERRY by

Drug Labeling and Warnings

ORAL SALINE LAXATIVE CHERRY by is a Otc medication manufactured, distributed, or labeled by Natureplex, LLC, 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 2.7g	Saline laxative
Monobasic Sodium Phosphate 7.2g	Saline laxative

Use

• relieves occasional constipation
• this product generally produces bowel movement in 30 minutes to 6 hours

Warnings

Dosage Warning

Taking more than the recommended dosage in 24 hours can be harmful.

Do not use

• if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, or uncorrected electrolyte abnormalities
• in children under 6 years old
• for bowel cleansing

Ask a doctor before use if you

• have abdominal pain, nausea, or vomiting
• have kidney disease
• have heart problems
• have a sudden change in bowel habits lasting more than 2 weeks
• have already used a laxative for more than 3 days
• are dehydrated
• are 55 years of age or older
• are on a sodium-restricted diet
• under a doctor's care for any medical condition
• are taking any other prescription or non-prescription medications

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

• do not use more than directed. Serious side effects may occur from excess dosage.
• do not use for more than 3 days, without asking a doctor

Stop use and ask a doctor if

• you have rectal bleeding
• you do not have a bowel movement within 6 hours
• you have any symptoms that your body is losing more fluid than you are drinking
• you have early 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 (or as directed by a doctor)

• 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 fluid when using this product. To prevent dehydration, drink plenty of clear liquids after use.
• Do not use for bowel cleansing
• There are 3 teaspoons in 1 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 and older	1 TABLEspoon	2 to 3 TABLEspoons*
10 to 11	1 TABLEspoon*	1 TABLEspoon*
6 to 9	1 teaspoons*	2 teaspoons*
Under 6	ASK A DOCTOR	ASK A DOCTOR

Other information

• each tablespoon contains: 1.6 g sodium
• 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)
• Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING.

Inactive ingredients

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

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton

FOR DIRECTIONS LIFT SIDE PANEL

Natureplex™

ORAL SALINE
NDC: 67234-041-01

Laxative
Phosphate

For Relief Of
Occasional
Constipation

Cherry
Splash

1.5 Fl Oz (45 mL)

INGREDIENTS AND APPEARANCE

ORAL 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: 67234-041
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 CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	1.4 g  in 14.7868 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	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)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-041-01	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 - Natureplex, LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-041)