Quality Choice Single Saline
FDA Label NDC 63868-380

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cdma for the product Quality Choice Single Saline (NDC 63868-380). 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 C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995

Otc - Purpose

Active ingredients (in each 118mL 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
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • 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 condtion 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: 800-222-1222.

Directions

Single daily dosage (per 24 hours)
Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphate product.

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 top or bottom flap of the 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 - 133 Ml Bottle Carton

NDC# 63868-380-45

QC®
QUALITY
CHOICE

* Compare to the
active ingredients
in FLEET ® Enema

Enema

Relieves Occasional
Constipation

Complete, Ready-to-Use

SODIUM PHOSPHATES
RECTAL SOLUTION

Latex Free

Comfortable,
Lubricated Tip

Works In
Minutes

1
Bottle
4.5 Fl Oz (133 mL)

Principal Display Panel (133 mL Bottle Carton)

Principal Display Panel (133 mL Bottle Carton)

* Please review the disclaimer below.