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NDC 00904-6320-78 Saline Laxative 7; 19 g/133mL; g/133mL Details

Saline Laxative 7; 19 g/133mL; g/133mL

Saline Laxative is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.

Product Information

NDC	00904-6320
Product ID	0904-6320_c4fb146c-fbdd-460e-8d33-d8f36fb39077
Associated GPIs	46109902105100
GCN Sequence Number	003029
GCN Sequence Number Description	sodium phosphate,mono-dibasic ENEMA 19G-7G/118 RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	66559
HICL Sequence Number	001330
HICL Sequence Number Description	SODIUM PHOSPHATE,MONOBASIC/SODIUM PHOSPHATE,DIBASIC
Brand/Generic	Brand
Proprietary Name	Saline Laxative
Proprietary Name Suffix	n/a
Non-Proprietary Name	Saline Laxative
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	7; 19
Active Ingredient Units	g/133mL; g/133mL
Substance Name	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6320-78 (00904632078)

Pricing Information
NDC Package Code	0904-6320-78
Billing NDC	00904632078
Package	133 mL in 1 BOTTLE (0904-6320-78)
Marketing Start Date	2013-07-11
NDC Exclude Flag	N
Price Per Unit	0.00808
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ENEMA READY TO USE
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b3758ffe-1bac-4df6-9714-5e33e9d28d90 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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

Use

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

Warnings

Dosage warning

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

For rectal use only.

Do not use

on children under 2 years of age

Ask a doctor before use if you

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

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

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

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.

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

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.

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

Other information

each 118 ml contains sodium 4.3 g
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

Questions or comments?

(800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

MAJOR®

NDC 0904-6320-78

Compare to the

active ingredients of

Fleet® Saline Enema*

Ready-to-Use

Enema

Saline Laxative

For relief of occasional

constipation

Not made with natural

rubber latex

4.5 FL OZ (133 mL)

1 Bottle

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

SALINE LAXATIVE

saline laxative enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6320
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g in 133 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	19 g in 133 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6320-78	133 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	07/11/2013

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
NATUREPLEX LLC		062808196	MANUFACTURE(0904-6320)

Revised: 3/2021

Document Id: c4fb146c-fbdd-460e-8d33-d8f36fb39077

Set id: b3758ffe-1bac-4df6-9714-5e33e9d28d90

Version: 7

Effective Time: 20210323

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NDC 00904-6320-78 Saline Laxative 7; 19 g/133mL; g/133mL Details

Saline Laxative 7; 19 g/133mL; g/133mL

Product Information

Package

Package Images

NDC 00904-6320-78 (00904632078)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b3758ffe-1bac-4df6-9714-5e33e9d28d90 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Use

Warnings

Dosage warning

Do not use

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

Directions (or as directed by a doctor)

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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