Drugplain

Soothe 6 mg/mL

glycerin and propylene glycol · SOLUTION/ DROPS · Bausch & Lomb Incorporated

2 Recalls on Record
Plain English

Soothe is an over-the-counter eye drop solution containing glycerin and propylene glycol that helps relieve dry eye symptoms by lubricating and moisturizing the eyes. It is applied directly to the eyes as needed for comfort.

Key Facts

Brand Name
Soothe
Generic Name
glycerin and propylene glycol
NDC Code (Product)
24208-495
Manufacturer
Bausch & Lomb Incorporated
Strength
6 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Drug Class
Non-Standardized Chemical Allergen [EPC]
Marketing Start
08/26/2010

Recall History

2 Recalls on Record
Class II12/07/2018

US Pharmaceuticals Inc.

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue5,031 reports
off label use4,455 reports
nausea4,453 reports
pain4,270 reports
drug ineffective4,211 reports
dyspnoea4,012 reports
diarrhoea3,843 reports
vomiting3,743 reports
headache3,322 reports
pneumonia3,286 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage & Administration

Directions find the right dose on chart below based on weight (preferred); otherwise use age chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose as needed do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor Dosing Chart Weight (lb) Age (yr) Dose (chewable tablets) under 24 under 2 ask a doctor 24-47 2-5 1 tablet 48-95 6-11 2 tablets

Warnings

Warnings Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the reach of children.

Frequently Asked Questions

What is Soothe used for?

Soothe is an over-the-counter eye drop solution containing glycerin and propylene glycol that helps relieve dry eye symptoms by lubricating and moisturizing the eyes. It is applied directly to the eyes as needed for comfort.

Is Soothe a controlled substance?

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

What is the generic name for Soothe?

The generic name for Soothe is glycerin and propylene glycol. There are 1 other brand versions of glycerin and propylene glycol.

What is the NDC code for Soothe 6 mg/mL?

The NDC (National Drug Code) for Soothe 6 mg/mL is 24208-495, listed by Bausch & Lomb Incorporated.

Product NDC

24208-495

Package NDC

24208-495-30

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

Data from openFDA · Public domain (CC0 1.0)