Cvs Pharmacy

Cvs Pharmacy
SPL v3
SPL
SPL Set ID 47ffb719-ad13-4530-b1a0-c419c801913a
Route
RECTAL
Published
Effective Date 2017-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (3.5 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-20

Description

Drug Facts


Medication Information

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 50566-9

Stop use and ask a doctor if the child

  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizzyness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.
Section 50567-7

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, without asking a doctor
Section 50568-5

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.

Section 50569-3

Ask a doctor or pharmacist before using if the child

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
Section 55105-1
Active ingredients (in each 59 mL delivered dose) Purpose
Dibasic Sodium Phosphate 3.5g Saline laxative
Monobasic Sodium Phosphate 9.5g Saline laxative
Warnings

For rectal use only.

Directions

(or as directed by a doctor)

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.

children 2 to 11 years 1 bottle once daily
children under 2 years ask a doctor
Dosage Warning

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

Other Information
  • each 59 mL contains: sodium 2.2g
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: 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?

866-323-0107 or www.natureplex.com

Principal Display Panel 66 Ml Bottle Carton

CVS

Health

Compare to the active

ingredients in Fleet®

Pedia-Lax Enema*

NDC 59779-969-40

Children's

Ready-to-Use

Enema

SALINE LAXATIVE

  • Pre-mixed
  • For relief of occasional

    constipation
  • Lubricated tip

AGES

2-11

2.25 FL OZ (66 mL)


Structured Label Content

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 50566-9 (50566-9)

Stop use and ask a doctor if the child

  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizzyness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.
Section 50567-7 (50567-7)

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, without asking a doctor
Section 50568-5 (50568-5)

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.

Section 50569-3 (50569-3)

Ask a doctor or pharmacist before using if the child

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
Section 55105-1 (55105-1)
Active ingredients (in each 59 mL delivered dose) Purpose
Dibasic Sodium Phosphate 3.5g Saline laxative
Monobasic Sodium Phosphate 9.5g Saline laxative
Warnings

For rectal use only.

Directions

(or as directed by a doctor)

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.

children 2 to 11 years 1 bottle once daily
children under 2 years ask a doctor
Dosage Warning (Dosage warning)

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

Other Information (Other information)
  • each 59 mL contains: sodium 2.2g
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

Principal Display Panel 66 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton)

CVS

Health

Compare to the active

ingredients in Fleet®

Pedia-Lax Enema*

NDC 59779-969-40

Children's

Ready-to-Use

Enema

SALINE LAXATIVE

  • Pre-mixed
  • For relief of occasional

    constipation
  • Lubricated tip

AGES

2-11

2.25 FL OZ (66 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)