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

Quality Choice by

Drug Labeling and Warnings

Quality Choice by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Use

• relieves occasional constipation
• this product generally produces bowel movement in 1 to 5 minutes

Warnings

Dosage warning

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

For rectal use only.

Do not use

• on children under 2 years of age

Ask a doctor before use if you

• have already used a laxative for more than 3 days
• have kidney disease, have heart problems, or are dehydrated
• are 55 years of age or older
• are on a sodium-restricted diet
• have abdominal pain, nausea, or vomiting
• have a sudden change in bowel habits lasting more than 2 weeks

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 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: 800-222-1222.

Directions (or as directed by a doctor)

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 of age and older: 1 bottle once daily
• Children 2 to under 12 years of age: Use Pediatric Enema
• Children under 2 years of age: DO NOT USE

Other information

• each 118 ml contains sodium 4.3 g
• store at 15 to 30°C (59 to 86°F)
• additional liquids by mouth are recommended while using this product
• Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-866-323-0107

SPL UNCLASSIFIED SECTION

Distributed by CDMA, Inc.
Novi, MI 48375

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 1 Bottle

NDC# 83324-292-45

QC®
QUALITY
CHOICE

* Compare to the
Active Ingredients
in FLEET ® Enema

Enema

Laxative

Complete, Ready-to-Use

SODIUM PHOSPHATES
RECTAL SOLUTION

Not Made
with Natural
Rubber Latex

Comfortable,
Lubricated Tip

Works In
Minutes

1
Bottle
4.5 Fl Oz (133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 2 Bottles

TWIN PACK

QC®
QUALITY
CHOICE

NDC# 83324-293-90

* Compare to the
Active Ingredients
in FLEET ® Enema

Enema

Laxative

Complete, Ready-to-Use

SODIUM PHOSPHATES
RECTAL SOLUTION

Not Made with
Natural Rubber Latex

Comfortable,
Lubricated Tip

Works In
Minutes

2
Bottles
4.5 Fl Oz (133 mL) Each

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-292
Route of Administration	RECTAL

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	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (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 ANHYDROUS (UNII: 8NLQ36F6MM)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-292-45	1 in 1 CARTON	06/01/2010
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 drug	M007	06/01/2010

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-293
Route of Administration	RECTAL

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	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (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 ANHYDROUS (UNII: 8NLQ36F6MM)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-293-90	2 in 1 CARTON	06/01/2010
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 drug	M007	06/01/2010

Labeler - Chain Drug Marketing Association (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(83324-292, 83324-293)