Drugplain

Medline 10 mg/1

cetirizine hcl · TABLET · Medline Industries, LP

10 Recalls on Record
Plain English

Medline is a tablet containing cetirizine hcl at 10 mg/1, taken oral. Manufactured by Medline Industries, LP.

Key Facts

Brand Name
Medline
Generic Name
cetirizine hcl
NDC Code (Product)
53329-033
Manufacturer
Medline Industries, LP
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA209274
Marketing Start
05/01/2020

Recall History

10 Recalls on Record
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II07/07/2025

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

OngoingVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class I09/25/2015

Medline Industries Inc

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use25,390 reports
fatigue23,401 reports
drug ineffective23,039 reports
pain21,297 reports
nausea21,100 reports
headache19,135 reports
dyspnoea17,228 reports
toxicity to various agents17,127 reports
vomiting16,168 reports
arthralgia15,891 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues temporarily protects irritated areas temporarily relieves burning provides temporary relief from skin irritations temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful temporarily protects inflamed perianal skin temporarily relieves the symptoms of perianal skin irritation may provide a cooling sensation

Dosage & Administration

Directions adults : when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily Children under 12 years of age : consult a doctor

Warnings

Warnings For external use only Allergy Alert: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days in case of bleeding Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Medline used for?

Medline contains cetirizine hcl. It is a tablet taken oral. Consult your doctor for specific uses.

Is Medline a controlled substance?

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

What is the generic name for Medline?

The generic name for Medline is cetirizine hcl. There are 12 other brand versions of cetirizine hcl.

What is the NDC code for Medline 10 mg/1?

The NDC (National Drug Code) for Medline 10 mg/1 is 53329-033, listed by Medline Industries, LP.