FDA.reportPublic FDA data

FREDS SALINE TWIN PACK

Manufacturer
FRED'S | NATUREPLEX LLC
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:09

Label at a glance#

ProductFREDS SALINE TWIN PACK LAXATIVE
Active ingredientSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Label structure10 sections

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 . Adults and children 12 years old and older 1 bottle once daily Children 2 to under 12 years old Use Pediatric Enema Children under 2 years DO NOT USE

Storage and handling

each 118 ml contains 4.3 g 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#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

  • relieves occasional constipation
  • this product generally produces a 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.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasing more than 2 weeks

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 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 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.

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.

Adults and children 12 years old and older1 bottle once daily
Children 2 to under 12 years oldUse Pediatric Enema
Children under 2 yearsDO NOT USE

Other information

STORAGE AND HANDLING SECTION

  • each 118 ml contains 4.3 g 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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55315-301-01

fred's
Pharmacy

SALINE
enema
TWIN PACK

For Relief of
Occasional
Constipation

Ready-to-Use
Soft, Easy to use Bottle
Not Made with Natural
Rubber Latex

2
BOTTLES
4.5 FL OZ (133 mL) each

Compare To
Fleet®*

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 133 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 EnemaPSN1
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD1
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY1
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY1

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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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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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
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55315-301-01FREDS SALINE TWIN PACK LAXATIVE133 mL in 1 BOTTLE, PLASTICENEMA1331
55315-301-01FREDS SALINE TWIN PACK LAXATIVE2 in 1 CARTONENEMA21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55315-301FREDS SALINE TWIN PACK LAXATIVE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [FRED'S]1Current NDC, Legacy NDC, 2 package rows20191220_7d15057f-eb3b-477f-ab14-68c3c38ea910.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
55315-30155315-301-01

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
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
FREDS SALINE TWIN PACK LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMFRED'S7d15057f-eb3b-477f-ab14-68c3c38ea9102018-12-26WarningsExact identifier
ndc (package): 55315-301-01
ndc (product): 55315-301
ndc11 (package): 55315030101
spl id: a3afd43d-bf5f-4044-9952-243aac1251fa
spl set id: 7d15057f-eb3b-477f-ab14-68c3c38ea910

Reported adverse events (FAERS/openFDA)#

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