Sunmark Saline Single Enema
FDA Label NDC 49348-186

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark Saline Single (NDC 49348-186). 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 McKesson
One Post Street, San Francisco, CA 94104

Otc - Purpose

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

sunmark®

COMPARE TO
FLEET® ENEMA SALINE
ACTIVE INGREDIENTS*

NDC 49348-186-20

complete &
ready-to-use

enema

Saline Laxative

For relief of
occasional constipation

Soft, flexible
Comfort tip

Pre-mixed

Protective shield
prevents
contamination

Comfortable,
lubricated tip for
ease of insertion

One-way safety valve
controls flow and
prevents reflux

Easy, soft squeeze
bottle

LATEX FREE

4.5 FL OZ
(133 ml)

* Please review the disclaimer below.