PURE AND GENTLE LAXATIVE- sodium phosphate enema

Pure and Gentle Laxative by

Drug Labeling and Warnings

Pure and Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. 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 old and older: 1 bottle once daily
• Children 2 to under 12 years old: Use Pediatric Enema
• Children under 2 years: 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?

866-323-0107

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Box

MEDLINE

NDC: 53329-014-11

Pure
&
Gentle®

Saline
Enema
Laxative

Comfortable
Lubricated Tip

Easy to Insert

Ready-to-Use

Not made with
Natural Rubber Latex

1 - 4.5 fl oz (133 mL)

INGREDIENTS AND APPEARANCE

PURE AND GENTLE LAXATIVE 
sodium phosphate enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-014
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 (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-014-11	1 in 1 BOX	11/10/2017
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 53329-014-58	24 in 1 CASE	11/03/2017
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	04/09/2014

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(53329-014)