TOPCARE ENEMA- dibasic sodium phosphate, monobasic sodium phosphate enema 
Topco Associates LLC

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.

----------

TOPCARE® ENEMA SALINE LAXATIVE
LAXATIVE

Drug Facts

Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

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

  • already used a laxative for more than 1 week
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet

Ask a doctor before using any laxative if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

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 bleeding
  • condition worsens or does not improve within 7 days
  • 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

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 older1 bottle once daily
Children 2 to under 12 years oldUse Pediatric Enema
Children under 2 yearsDO NOT USE

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

TopCare®
health

NDC 36800-002-02

COMPARE TO FLEET® ENEMA SALINE
ACTIVE INGREDIENTS*

Enema
Saline
Laxative

1 BOTTLE

4.5 FL OZ (133 mL)

Principal Display Panel - 133 mL Bottle Carton
TOPCARE ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-002
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 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:36800-002-021 in 1 CARTON11/05/2009
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:36800-002-362 in 1 CARTON11/05/2009
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 finalpart33411/05/2009
Labeler - Topco Associates LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(36800-002)

Revised: 1/2019
Document Id: b7dd72f7-51ad-466a-90f4-deabf2c0a22c
Set id: 4dfe410b-9248-4549-8bc4-3d3c35e2569d
Version: 5
Effective Time: 20190118
 
Topco Associates LLC