TOPCARE ENEMA- dibasic sodium phosphate, monobasic sodium phosphate enema

topcare enema by

Drug Labeling and Warnings

topcare enema by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Natureplex LLC. 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

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 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 4.3 g sodium
• store at 15 to 30°C (59 to 86°F)
• additional liquids by mouth are recommended while using this product
• this product generally produces a bowel movement in 1 to 5 minutes
• carton sealed for safety. 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?

1-888-423-0139

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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

• For Relief of
  Occasional Constipation
• Soft, Flexible Tip
• Not Made with Natural
  Rubber Latex
• Ready-to-Use
  Squeeze Bottle

1 BOTTLE

4.5 FL OZ (133 mL)

INGREDIENTS AND APPEARANCE

TOPCARE ENEMA 
dibasic sodium phosphate, monobasic sodium phosphate enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-002
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37)	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: 36800-002-02	1 in 1 CARTON	11/05/2009
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 36800-002-36	2 in 1 CARTON	11/05/2009
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	11/05/2009

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(36800-002)