Saline 6.5 mg/mL
Saline · SPRAY · FAMILY DOLLAR SERVICES INC
Saline is a spray containing saline at 6.5 mg/mL, taken nasal. Manufactured by FAMILY DOLLAR SERVICES INC.
Key Facts
- Brand Name
- Saline
- Generic Name
- Saline
- NDC Code (Product)
55319-047- Manufacturer
- FAMILY DOLLAR SERVICES INC
- Strength
- 6.5 mg/mL
- Dosage Form
- SPRAY
- Route
- NASAL
- Marketing Status
- Application #
- M022
- Marketing Start
- 07/28/2020
Recall History
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Walgreens Infusion Services
Lack of sterility assurance.
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Pharma Nobis LLC
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Vi-Jon, Inc.
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Pharma Nobis LLC
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Walgreens Infusion Services
Lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 Saline. 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 Saline. There are 5 other brand versions of Saline.
What is the NDC code for Saline 6.5 mg/mL?
The NDC (National Drug Code) for Saline 6.5 mg/mL is 55319-047, listed by FAMILY DOLLAR SERVICES INC.