QUALITY CHOICE SINGLE SALINE LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

QUALITY CHOICE SINGLE SALINE by

Drug Labeling and Warnings

QUALITY CHOICE SINGLE SALINE by is a Otc medication manufactured, distributed, or labeled by Alcyon Health, LLC., Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 118 mL delivered dose)	Purpose
Dibasic Sodium Phosphate 7 g	Saline laxative
Monobasic Sodium Phosphate 19 g	Saline laxative

Use

Relieves occasional constipation

Warnings

For rectal use only

Dosage warning

Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you

• already used a laxative for more than 1 week
• are dehydrated
• have kidney disease
• are 55 years old or older
• have heart problems
• are on a sodium-restricted diet

Ask a doctor before using any laxative if you have

• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits lasting more than 2 weeks
• already used a laxative for more than 1 week

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

Stop use and ask a doctor if

• you have bleeding
• the condition worsens or does not improve within 7 days
• you have no bowel movement within 30 minutes of enema use
• you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

• Adults and Children 12 years old and older: 1 bottle once daily
• Children 2 to under 12 years old: 1/2 bottle once daily
• Children under 2 years: DO NOT USE

Other information

• each 118 ml contains 4.4 g sodium
• store at 15 to 30°C (59 to 86°F)
• additional liquids by mouth are recommended while using this product
• this product generally produces a bowel movement in 1 to 5 minutes
  carton sealed for safety. Do not use if the top or bottom flap of the carton is torn or missing

Inactive ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-844-624-2633 or www.maiamed.com

SPL UNCLASSIFIED SECTION

Distributed By:
Maia Medical
655 Metro Place South, Suite 600-050
Dublin, OH 43017 USA

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

maia
medical™

SALINE
enema

6 Bottles
4.5 Fl Oz (133 ml) each

Latex Free

INGREDIENTS AND APPEARANCE

QUALITY CHOICE SINGLE SALINE   LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71443-001
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	19 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71443-001-06	6 in 1 CARTON	07/05/2017
1		133 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	07/05/2017

Labeler - Alcyon Health, LLC. (080040408)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(71443-001)