Drugplain

Saline 6.5 mg/mL

Nasal · SPRAY · BEST CHOICE (VALU MERCHANDISERS COMPANY)

10 Recalls on Record
Plain English

Saline is a spray containing nasal at 6.5 mg/mL, taken nasal. Manufactured by BEST CHOICE (VALU MERCHANDISERS COMPANY).

Key Facts

Brand Name
Saline
Generic Name
Nasal
NDC Code (Product)
63941-704
Manufacturer
BEST CHOICE (VALU MERCHANDISERS COMPANY)
Strength
6.5 mg/mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M022
Marketing Start
10/19/2020

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II12/26/2014

Walgreens Infusion Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class III03/07/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

TerminatedVoluntary: Firm initiated
Class II04/02/2019

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Lack of sterility assurance.

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 II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: 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 II12/26/2014

Walgreens Infusion Services

Lack of sterility assurance.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea6,577 reports
off label use5,790 reports
dyspnoea5,614 reports
fatigue5,130 reports
headache5,116 reports
myelosuppression4,810 reports
pyrexia4,751 reports
vomiting4,659 reports
diarrhoea4,623 reports
pain4,453 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 used for?

Saline contains Nasal. It is a spray taken nasal. Consult your doctor for specific uses.

Is Saline a controlled substance?

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

What is the generic name for Saline?

The generic name for Saline is Nasal. There are 10 other brand versions of Nasal.

What is the NDC code for Saline 6.5 mg/mL?

The NDC (National Drug Code) for Saline 6.5 mg/mL is 63941-704, listed by BEST CHOICE (VALU MERCHANDISERS COMPANY).