FDA.reportPublic FDA data

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:05

Label at a glance#

ProductREFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE
Active ingredientSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

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

Dosage and administration

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 age Use 1 bottle once daily children under 2 years of age DO NOT USE

Storage and handling

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.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 59 ml delivered dose)Purpose
Dibasic Sodium Phosphate 3.5g.....Saline laxative
Monobasic Sodium Phosphate 9.5g.....Saline laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only.

Dosage warning:

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age

Ask a doctor before use if the child

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if the child

OTC - STOP USE SECTION

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions (or as directed by a doctor)

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free at +1-855-452-9500 or email info@Leosonsintl.com

Distributed by:

SPL UNCLASSIFIED SECTION


Leosons
10 Maryland Avenue
Albany, New York 12205

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonPRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN3
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD3
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY3
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0085-7REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE1 in 1 CARTONENEMA13
69626-0085-7REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE67 mL in 1 BOTTLE, PLASTICENEMA673

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0085REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [LEOSONS OVERSEAS CORP]3Current NDC, Legacy NDC, 2 package rows20241121_90e7c2b4-35e1-4a27-afea-9257c480e190.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-008569626-0085-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
ndc (package): 69626-0085-7
ndc (product): 69626-0085
ndc11 (package): 69626008507
spl id: 274788d7-9fec-5b62-e063-6294a90ad899
spl set id: 90e7c2b4-35e1-4a27-afea-9257c480e190

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.