Relief Enema
FDA Label NDC 69626-0084

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leosons Overseas Corp for the product Relief (NDC 69626-0084). 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 using this product if you, ask a doctor before using any laxative if you have, stop use and ask a doctor if you have, 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:
Leosons
10 Maryland Avenue
Albany, New York 12205

Otc - Purpose

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

Use

for relief of occasional constipation

Warnings

For rectal use only

Dosage Warning

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

Ask A Doctor Before Using This Product If You

  • are on a sodium-restricted diet
  • have kidney disease
  • are 65 or older and under a doctor's care for any medical condition

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

Stop Use And Ask A Doctor If You Have

  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, 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

Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphates product.

Adults and Children 12 years and over1 Bottle
Children 2 to under 12 years1/2 Bottle once daily
Children under 2 yearsDO NOT USE

Other Information

  • each 118 mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1-5 minutes
  • store between 15°- 30°C (59°- 86°F)
  • carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
  • consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.

Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

Principal Display Panel - 133 Ml Bottle Carton

RELIEF™

SALINE LAXATIVE

Ready-to-Use
ENEMA

For relief of
occasional
constipation

  • Pre-Mixed
  • Latex Free

    • Lubricated Tip
    1 Bottle 4.5 FL OZ (133mL)

    Principal Display Panel (133 mL Bottle Carton)

    Principal Display Panel (133 mL Bottle Carton)

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