Saline Laxative

Saline Laxative
SPL v5
SPL
SPL Set ID 344100dc-0c83-4c3e-aaa6-dfd6398a20df
Route
RECTAL
Published
Effective Date 2019-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (7 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-31

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 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 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
Warnings

For rectal use only.

Do Not Use
  • on children under 2 years of age
Dosage Warning

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

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
  • 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?

1-877-932-7948

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
Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • 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
  • 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
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
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.

Adults and children 12 years of age and older 1 bottle once daily
Children 2 to under 12 years of age Use Pediatric Enema
Children under 2 years of age DO NOT USE
Principal Display Panel 133 Ml Bottle Carton

NDC 41163-005-11

compare to

Fleet®

Enema Saline

active ingredients*

EQUALINE®

complete and

ready-to-use

enema

saline laxative

for relief of

occasional

constipation

  • premixed
  • soft, flexible

    comfort tip

1 BOTTLE

4.5 FL OZ

(133mL)


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 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 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
Warnings

For rectal use only.

Do Not Use (Do not use)
  • on children under 2 years of age
Dosage Warning (Dosage warning)

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

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
  • 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?)

1-877-932-7948

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, without asking a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • 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)
  • 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
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks
Directions (or As Directed By A Doctor) (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.

Adults and children 12 years of age and older 1 bottle once daily
Children 2 to under 12 years of age Use Pediatric Enema
Children under 2 years of age DO NOT USE
Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton)

NDC 41163-005-11

compare to

Fleet®

Enema Saline

active ingredients*

EQUALINE®

complete and

ready-to-use

enema

saline laxative

for relief of

occasional

constipation

  • premixed
  • soft, flexible

    comfort tip

1 BOTTLE

4.5 FL OZ

(133mL)


Advanced Ingredient Data


Raw Label Data

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