FDA.reportPublic FDA data

RITE AID LAXATIVE SALINE

Manufacturer
RITE AID | Natureplex, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:13

Label at a glance#

ProductRITE AID LAXATIVE SALINE 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 of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age 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 118 mL 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 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 you

OTC - ASK DOCTOR SECTION

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting 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 of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO 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

Questions or comments?

OTC - QUESTIONS SECTION

866-323-0107

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-0604-1

FREE
FROM
PARABEN
FREE

Compare to the active
ingredients in Fleet® Enema*

LAXATIVE
SALINE
ENEMA

DIBASIC SODIUM PHOSPHATE 7 g
MONOBASIC SODIUM PHOSPHATE 19 g

READY TO USE

not made with natural rubber latex

for relief of occasional constipation

easy, soft squeeze bottle

2
BOTTLES

4.5 FL OZ (133 mL) EACH

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 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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0604-12026-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-22026-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-32026-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-12021-07-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-22021-07-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-32021-07-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-12021-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-22021-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE
11822-0604-32021-01-29C16284748780-1ba0f9c33-4896-a910-e053-dadaa90a0b85RITE AID LAXATIVE SALINE ENEMA LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0604-1RITE AID LAXATIVE SALINE LAXATIVE133 mL in 1 BOTTLE, PLASTICENEMA1333
11822-0604-1RITE AID LAXATIVE SALINE LAXATIVE2 in 1 CARTONENEMA23
11822-0604-2RITE AID LAXATIVE SALINE LAXATIVE6 in 1 CARTONENEMA63
11822-0604-2RITE AID LAXATIVE SALINE LAXATIVE133 mL in 1 BOTTLE, PLASTICENEMA1333
11822-0604-3RITE AID LAXATIVE SALINE LAXATIVE12 in 1 CARTONENEMA123
11822-0604-3RITE AID LAXATIVE SALINE LAXATIVE133 mL in 1 BOTTLE, PLASTICENEMA1333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0604RITE AID LAXATIVE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [RITE AID]3Legacy NDC, 6 package rows20250101_d98a9ca0-e79c-471f-b7d8-1d13c778c094.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
11822-060411822-0604-1, 11822-0604-2, 11822-0604-3

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

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
19390348-513c-438a-a1c1-5da456b34c44d98a9ca0-e79c-471f-b7d8-1d13c778c0942024-12-31WarningsExact identifier
spl id: 19390348-513c-438a-a1c1-5da456b34c44
spl set id: d98a9ca0-e79c-471f-b7d8-1d13c778c094

Reported adverse events (FAERS/openFDA)#

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