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

Pediatric by

Drug Labeling and Warnings

Pediatric by is a Otc medication manufactured, distributed, or labeled by Natureplex, LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 old: 1 bottle once daily
• children under 2 years: 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?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton

Natureplex™

pediatric
ages 2-11

NDC: 67234-042-01

ENEMA

*Compare
To
Fleet®

saline laxative

• Not Made with Natural
  Rubber Latex
• Pre-mixed
• For relief of
  occasional
  constipation
• Pre-lubricated tip

1
Bottle
2.25 Fl Oz
(67 mL)

INGREDIENTS AND APPEARANCE

PEDIATRIC   SALINE LAXATIVE
sodium phosphate, monobasic, unspecified form and sodium phosphate, dibasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-042
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	3.5 g  in 59 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, 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: 67234-042-01	1 in 1 CARTON	08/31/2012
1		67 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	08/31/2012

Labeler - Natureplex, LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-042)