RELIEF- sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema

RELIEF by

Drug Labeling and Warnings

RELIEF by is a Otc medication manufactured, distributed, or labeled by Leosons Overseas Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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

Use

for relief of occasional constipation

Warnings

For rectal use only

Dosage Warning

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

Ask a doctor before using this product if you

• are on a sodium-restricted diet
• have kidney disease
• are 65 or older and under a doctor's care for any medical condition

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

Stop use and ask a doctor if you have

• rectal bleeding
• no bowel movement within 30 minutes of enema use
• symptoms of dehydration (feeling thirsty, 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

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

Do not use if taking another sodium phosphates product.

• Adults and Children 12 years and over: 1 Bottle
• Children 2 to under 12 years: 1/2 Bottle once daily
• Children under 2 years: DO NOT USE

Other information

• each 118 mL delivered dose contains: sodium 4.4 g
• additional liquids by mouth are recommended while using this product
• this product generally produces a bowel movement in 1-5 minutes
• store between 15°- 30°C (59°- 86°F)
• carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
• consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.

Inactive ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions?

Call toll-free at +1-855-452-9500 or email info@Leosonsintl.com

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Distributed by:
Leosons
10 Maryland Avenue
Albany, New York 12205

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

RELIEF™

SALINE LAXATIVE

Ready-to-Use
ENEMA

For relief of
occasional
constipation

• Pre-Mixed
• Latex Free

Lubricated Tip
1 Bottle 4.5 FL OZ (133mL)

INGREDIENTS AND APPEARANCE

RELIEF 
sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69626-0084
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC	19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	7 g  in 133 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: 69626-0084-6	1 in 1 CARTON
1		133 mL in 1 BOTTLE, WITH APPLICATOR; 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	02/09/2015

Labeler - Leosons Overseas Corp (148605470)