Reflief Saline Laxative Pediatric Ready To Use Enema
FDA Label NDC 69626-0085

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 Reflief Saline Laxative Pediatric Ready To Use (NDC 69626-0085). 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, do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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 59 ml delivered dose)Purpose
Dibasic Sodium Phosphate 3.5gSaline laxative
Monobasic Sodium Phosphate 9.5gSaline laxative

Use

  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes

Warnings

For rectal use only.

Dosage Warning

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

Do Not Use

  • on children under 2 years of age

Otc - Ask Doctor

Ask a doctor before use if the child

  • has already used a laxative for more than 3 days
  • has kidney disease, have heart problems, or are dehydrated
  • is on a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has a sudden change in bowel habits lasting more than 2 weeks

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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, without asking a doctor

Otc - Stop Use

Stop use and ask a doctor if the child

  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

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 (Or As Directed By A Doctor)

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.

children 2 to under 12 years of ageUse 1 bottle once daily
children under 2 years of ageDO NOT USE

Other Information

  • each 59 mL contains 2.2g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Principal Display Panel - 67 Ml Bottle Carton

NDC 69626-0085-7

RELIEF™
SALINE LAXATIVE

Pediatric
Ready-to-Use

ENEMA

For relief of
occasional
constipation

  • Pre-Mixed
  • Not Made
    With Natural
    Rubber Latex

    • Ages 2-11

    Lubricated Tip
    2.25 FL OZ (67 mL)

    Principal Display Panel (67 mL Bottle Carton)

    Principal Display Panel (67 mL Bottle Carton)

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