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

Sunmark Saline Single by

Drug Labeling and Warnings

Sunmark Saline Single by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, 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)	Purposes
Dibasic Sodium Phosphate 7g	Saline laxative
Monobasic Sodium Phosphate 19g	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
• have kidney disease
• have heart problems
• are dehydrated
• are 55 years old or older
• 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 condtion 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: 800-222-1222.

Directions

Single daily dosage (per 24 hours)

Do not use more unless directed by a doctor.

See Warnings.

Do not use if taking another sodium phosphate product.

• 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 top or bottom flap of the carton is torn or missing

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

Distributed By McKesson
One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

sunmark®

COMPARE TO
FLEET® ENEMA SALINE
ACTIVE INGREDIENTS*

NDC: 49348-186-20

complete &
ready-to-use

enema

Saline Laxative

For relief of
occasional constipation

Soft, flexible
Comfort tip

Pre-mixed

Protective shield
prevents
contamination

Comfortable,
lubricated tip for
ease of insertion

One-way safety valve
controls flow and
prevents reflux

Easy, soft squeeze
bottle

LATEX FREE

4.5 FL OZ
(133 ml)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-186
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 Cation - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g  in 118 mL
Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW) (Phosphate Ion - UNII:NK08V8K8HR, Sodium Cation - UNII:LYR4M0NH37)	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: 49348-186-20	1 in 1 CARTON	03/06/2013
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49348-186-14	2 in 1 CARTON	03/06/2013
2		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	03/06/2013

Labeler - Strategic Sourcing Services LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(49348-186)