REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE by

Drug Labeling and Warnings

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE by is a Otc medication manufactured, distributed, or labeled by Leosons International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 59 ml delivered dose)	Purpose
Dibasic Sodium Phosphate 3.5g	Saline laxative
Monobasic Sodium Phosphate 9.5g	Saline laxative

Use

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

Warnings

For rectal use only.

Dosage warning

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

Do not use

• on children under 2 years of age

Ask a doctor before use if the child

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

Ask a doctor or pharmacist before use if the child is 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 the child

• has rectal bleeding
• has no bowel movement within 30 minutes of enema use
• has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

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.

• children 2 to under 12 years of age: Use 1 bottle once daily
• children under 2 years of age: DO NOT USE

Other information

• each 59 mL contains 2.2g sodium
• 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?

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 - 67 mL Bottle Carton

NDC: 69626-0085-7

RELIEF™
SALINE LAXATIVE

Pediatric
Ready-to-Use

ENEMA

For relief of
occasional
constipation

• Pre-Mixed
• Not Made
  With Natural
  Rubber Latex

Ages 2-11

Lubricated Tip
2.25 FL OZ (67 mL)

INGREDIENTS AND APPEARANCE

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE 
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69626-0085
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	3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	9.5 g  in 59 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: 69626-0085-7	1 in 1 CARTON	10/01/2019
1		67 mL in 1 BOTTLE, PLASTIC; 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	10/01/2019

Labeler - LEOSONS OVERSEAS CORP (148605470)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(69626-0085)