FDA.reportPublic FDA data

ORAL SALINE LAXATIVE LEMON GINGER

Manufacturer
Natureplex, LLC | Natureplex LLC
Effective date
2018-06-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:55:57

Label at a glance#

ProductORAL SALINE LAXATIVE LEMON GINGER
Active ingredientSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Label structure9 sections

Dosage and administration

Use as a laxative for relief of occasional constipation Dilute dose in the table below with one glass (8 fl oz) of cool water. Drink, then follow with at least one additional glass (8 fl oz) of cool water. There is significant loss of fluid when using this product. To prevent dehydration, drink plenty of clear liquids after use. Do not use for bowel cleansing There are 3 teaspoons in 1 TABLEspoon Do not take more ...

Storage and handling

each tablespoon contains: 1.6 g sodium saline laxatives increase retention of water in the intestines, promoting bowel movements this product generally produces a bowel movement in 30 minutes to 6 hours this product is sugar-free do not freeze store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablespoon)Purpose
Dibasic Sodium Phosphate 2.7gSaline laxative
Monobasic Sodium Phosphate 7.2gSaline laxative

Use

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • this product generally produces bowel movement in 30 minutes to 6 hours

Warnings

WARNINGS SECTION

Dosage Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dosage in 24 hours can be harmful.

Do not use

OTC - DO NOT USE SECTION

  • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, or uncorrected electrolyte abnormalities
  • in children under 6 years old
  • for bowel cleansing

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have abdominal pain, nausea, or vomiting
  • have kidney disease
  • have heart problems
  • have a sudden change in bowel habits lasting more than 2 weeks
  • have already used a laxative for more than 3 days
  • are dehydrated
  • are 55 years of age or older
  • are on a sodium-restricted diet
  • under a doctor's care for any medical condition
  • are taking any other prescription or non-prescription medications

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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

OTC - STOP USE SECTION

  • you have rectal bleeding
  • you do not have a bowel movement within 6 hours
  • you have any symptoms that your body is losing more fluid than you are drinking
  • you have early symptoms of dehydration including
    • thirstiness
    • dizziness
    • urinating less often than normal
    • vomiting

These symptoms may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions (or as directed by a doctor)

DOSAGE & ADMINISTRATION SECTION

  • Use as a laxative for relief of occasional constipation
  • Dilute dose in the table below with one glass (8 fl oz) of cool water. Drink, then follow with at least one additional glass (8 fl oz) of cool water. There is significant loss of fluid when using this product. To prevent dehydration, drink plenty of clear liquids after use.
  • Do not use for bowel cleansing
  • There are 3 teaspoons in 1 TABLEspoon
  • Do not take more unless directed by a doctor. See Warnings
Ages (years)DosageMaximum dose
12 and older1 TABLEspoon2 to 3 TABLEspoons*
10 to 111 TABLEspoon* 1 TABLEspoon*
6 to 91 teaspoons* 2 teaspoons*
Under 6ASK A DOCTORASK A DOCTOR

* SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD

Other information

STORAGE AND HANDLING SECTION

  • each tablespoon contains: 1.6 g sodium
  • saline laxatives increase retention of water in the intestines, promoting bowel movements
  • this product generally produces a bowel movement in 30 minutes to 6 hours
  • this product is sugar-free
  • do not freeze
  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, glycerin, purified water, saccharin sodium, sodium benzoate

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

◀ FOR DIRECTIONS LIFT SIDE PANEL

Natureplex™

ORAL SALINE
Laxative
Phosphate
For Relief Of
Occasional
Constipation

NDC 67234-044-01

Lemon
Ginger

1.5 Fl Oz (45 mL)

PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 45 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790675sodium phosphate, dibasic 1.4 GM / sodium phosphate, monobasic 6.2 GM in 15 mL Oral SolutionPSN3
1790675sodium phosphate, dibasic 93 MG/ML / sodium phosphate, monobasic 413 MG/ML Oral SolutionSCD3
1790675sodium phosphate, dibasic 1.4 GM / sodium phosphate, monobasic 6.2 GM per 15 ML Oral SolutionSY3

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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-044-012025-01-30C16284748780-12cef2736-68a1-d83d-e063-dadaa90ab31fORAL SALINE LAXATIVE LEMON GINGER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-044-01ORAL SALINE LAXATIVE LEMON GINGER1 in 1 CARTONLIQUID13
67234-044-01ORAL SALINE LAXATIVE LEMON GINGER45 mL in 1 BOTTLELIQUID453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-044ORAL SALINE LAXATIVE LEMON GINGER (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) LIQUID [NATUREPLEX, LLC]3Legacy NDC, 2 package rows20180616_777e48d8-95d7-414b-97cb-ddd0c2b3e313.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-04467234-044-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
e12c16df-924d-4cca-9370-88a02c2379dd777e48d8-95d7-414b-97cb-ddd0c2b3e3132018-06-15WarningsExact identifier
spl id: e12c16df-924d-4cca-9370-88a02c2379dd
spl set id: 777e48d8-95d7-414b-97cb-ddd0c2b3e313

Reported adverse events (FAERS/openFDA)#

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