CARE ONE ENEMA- saline enema 
American Sales Company

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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American Sales Company 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?

1-800-367-4477

Package/Label Principal Display Panel

Compare to the active ingredients in Fleet® Enema Saline

READY-TO-USE

ENEMA

Saline Laxative

LATEX FREE

For relief of occasional constipation

{Insert # of Packaged Bottles} Pack

Soft, Flexible

Comfort Tip

Enema Carton Image 1

Enema Carton Image 1

Enema Carton Image 2

Enema Carton Image 1

Enema Carton Image 2

CARE ONE ENEMA 
saline enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-002
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-002-021 in 1 CARTON01/18/201006/07/2014
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41520-002-362 in 1 CARTON01/18/201006/07/2014
2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/18/201006/07/2014
Labeler - American Sales Company (809183973)

Revised: 11/2017
Document Id: c36615d7-ab3b-4af7-872b-78ea252eefd5
Set id: 9ebb7596-ac6e-4377-af6e-738f656f9131
Version: 2
Effective Time: 20171113
 
American Sales Company