EQUALINE ENEMA- saline enema
Supervalu Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SuperValu Inc. Enema Drug Facts

Active ingredients (in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

•: 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 have

•: a sodium-restricted diet
•: abdominal pain, nausea or vomiting
•: kidney disease, heart problems, or are dehydrated
•: noticed a sudden change in bowel habits that lasts over 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

Stop use and ask a doctor if

•: you have rectal bleeding
•: you have no bowel movement after use of a laxative

These could be signs of 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. (1-800-222-1222)

Directions

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

adults & children 12 years and over	one bottle once daily
children 2 to under 12 years	½ bottle once daily
children under 2 years	do not use

Other information

•: each 118 mL contains: sodium 4.3 g
•: store at room temperature 20º-25ºC (68º-77ºF)
•: this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-877-932-7948

Package/Label Principal Display Panel

compare to Fleet® Enema Saline active ingredients

complete and ready-to-use

enema

saline laxative

for relief of occasional constipation

pre-mixed

latex free

soft, flexible comfort tip

{Insert # of Packaged Bottles} Pack

Enema Carton Image 1

Enema Carton Image 2

EQUALINE ENEMA
saline enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-002
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC	7 g in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC	19 g in 118 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-002-02	1 in 1 CARTON	11/06/2009	04/22/2015
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41163-002-36	2 in 1 CARTON	11/06/2009	04/22/2015
2		133 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/06/2009	04/22/2015

Labeler - Supervalu Inc (006961411)

Revised: 11/2017

Document Id: da45f93a-8cb2-4350-8fa1-961076d26d5b

Set id: cdd3a5a3-cbe3-4a70-af8d-74e41c026d54

Version: 2

Effective Time: 20171126

Supervalu Inc