Quality Choice Single Saline Enema
FDA Label NDC 71443-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcyon Health, Llc. for the product Quality Choice Single Saline (NDC 71443-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, dosage warning, ask a doctor before use if you, ask a doctor before using any laxative if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By:
Maia Medical
655 Metro Place South, Suite 600-050
Dublin, OH 43017 USA

Otc - Purpose

Active ingredients (in each 118 mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

Relieves occasional constipation

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
  • are dehydrated
  • have kidney disease
  • are 55 years old or older
  • have heart problems
  • 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
  • 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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 older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

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

Principal Display Panel - 133 Ml Bottle Carton

maia
medical™

SALINE
enema

6 Bottles
4.5 Fl Oz (133 ml) each

Latex Free

Principal Display Panel (133 ml Bottle Carton)

Principal Display Panel (133 ml Bottle Carton)

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