topcare®

topcare®
SPL v5
SPL
SPL Set ID 4dfe410b-9248-4549-8bc4-3d3c35e2569d
Route
rectal
Published
Effective Date 2019-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sodium cation (7 g)
Inactive Ingredients
benzalkonium chloride edetate disodium water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2009-11-05

Description

Drug Facts


Medication Information

Warnings

For rectal use only.

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

Description

Drug Facts

Use
  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative
Dosage Warning

Using more than one enema in 24 hours can be harmful.

Questions Or Comments?

1-888-423-0139

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.

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
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
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)

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

Structured Label Content

Warnings

For rectal use only.

Other Information (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 (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Use
  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative
Dosage Warning (Dosage warning)

Using more than one enema in 24 hours can be harmful.

Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (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 (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.

Ask A Doctor Before Use If You (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
Single Daily Dosage (per 24 Hours) (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
Principal Display Panel 133 Ml Bottle Carton (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)

Ask A Doctor Before Using Any Laxative If You Have (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)