Drugplain

Saline Laxative 7 g/133mL

Saline Laxative · ENEMA · Major Pharmaceuticals

10 Recalls on Record
Plain English

This is a saline enema used to relieve constipation by drawing water into the colon to soften stool and promote bowel movements. It is available over-the-counter and works quickly, typically producing results within a few minutes.

Key Facts

Brand Name
Saline Laxative
Generic Name
Saline Laxative
NDC Code (Product)
0904-6320
Manufacturer
Major Pharmaceuticals
Strength
7 g/133mL
Dosage Form
ENEMA
Route
RECTAL
Marketing Status
Application #
M007
Marketing Start
07/11/2013

Recall History

10 Recalls on Record
Class II12/21/2023

Pharma Nobis LLC

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

OngoingVoluntary: Firm initiated
Class II07/17/2017

Vi-Jon, Inc.

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

TerminatedVoluntary: Firm initiated
Class II12/21/2023

Pharma Nobis LLC

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

OngoingVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations;

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class II12/21/2023

Pharma Nobis LLC

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain1,527 reports
constipation1,371 reports
nausea1,260 reports
off label use1,254 reports
fall1,074 reports
drug ineffective1,038 reports
fatigue1,030 reports
diarrhoea972 reports
dyspnoea901 reports
mobility decreased876 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: • For relief of occasional constipation (irregularity). • Generally produces bowel movement in ½ to 6 hours

Dosage & Administration

Directions: • shake well before using • drink a full glass (8 ounces) of liquid with each dose • may be taken as a single daily dose or in divided doses adults and children 12 years of age and over 6.5 to 10 fl oz maximum 10 fl oz in 24 hours children 6 to under 12 years of age 3 to 7 fl oz maximum 7 fl oz in 24 hours children 2 to under 6 years of age 2 to 3 fl oz maximum 3 fl oz in 24 hours children under 2 years of age ask a doctor

Warnings

Warnings: Ask a doctor before use if you have • Kidney disease • a magnesium restricted diet • Abdominal pain, nausea, or vomiting • Noticed a sudden change in bowel habits that persists over a period of 2 weeks • Already used a laxative for a period longer than 1 week Ask a doctor or pharmacist before use if you are • Taking any other drug. • Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Saline Laxative used for?

This is a saline enema used to relieve constipation by drawing water into the colon to soften stool and promote bowel movements. It is available over-the-counter and works quickly, typically producing results within a few minutes.

Is Saline Laxative a controlled substance?

Saline Laxative is not classified as a controlled substance by the DEA.

What is the generic name for Saline Laxative?

The generic name for Saline Laxative is Saline Laxative. There are 1 other brand versions of Saline Laxative.

What is the NDC code for Saline Laxative 7 g/133mL?

The NDC (National Drug Code) for Saline Laxative 7 g/133mL is 0904-6320, listed by Major Pharmaceuticals.

Product NDC

0904-6320

Package NDC

0904-6320-78

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)