Quality Choice Single Saline Enema

Quality Choice Single Saline Enema
SPL v1
SPL
SPL Set ID eb499c7f-9c7b-4097-83a3-82aabffd6beb
Route
RECTAL
Published
Effective Date 2017-07-12
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 2017-07-05
Description

Drug Facts

Medication Information

Description

Drug Facts

Use

Relieves occasional constipation

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.

Section 53414-9

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

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

For rectal use only

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 1/2 bottle once daily
Children under 2 years DO NOT USE
Dosage Warning

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

Other Information
  • each 118 ml contains 4.4 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 the top or bottom flap of the carton is torn or missing
Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

1-844-624-2633 or www.maiamed.com

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
  • the 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
  • are dehydrated
  • have kidney disease
  • are 55 years old or older
  • have heart problems
  • are on a sodium-restricted diet
Principal Display Panel 133 Ml Bottle Carton

maia

medical™

SALINE

enema

6 Bottles

4.5 Fl Oz (133 ml) each

Latex Free

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

Use

Relieves occasional constipation

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.

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 118 mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative
Warnings

For rectal use only

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 1/2 bottle once daily
Children under 2 years DO NOT USE
Dosage Warning (Dosage warning)

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

Other Information (Other information)
  • each 118 ml contains 4.4 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 the top or bottom flap of the carton is torn or missing
Inactive Ingredients (Inactive ingredients)

Benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

1-844-624-2633 or www.maiamed.com

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
  • the 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
  • are dehydrated
  • have kidney disease
  • are 55 years old or older
  • have heart problems
  • are on a sodium-restricted diet
Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton)

maia

medical™

SALINE

enema

6 Bottles

4.5 Fl Oz (133 ml) each

Latex Free

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:23.597055 · Updated: 2026-03-14T22:54:48.761962