Drugplain

Soothe 525 mg/30mL

Bismuth subsalicylate · LIQUID · Walgreens

2 Recalls on Record
Plain English

Soothe is an over-the-counter liquid medication containing bismuth subsalicylate that is used to relieve symptoms of indigestion, heartburn, upset stomach, and diarrhea. Each 30 mL dose contains 525 mg of the active ingredient.

Key Facts

Brand Name
Soothe
Generic Name
Bismuth subsalicylate
NDC Code (Product)
0363-7240
Manufacturer
Walgreens
Strength
525 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
11/29/2019

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 liquid medication containing bismuth subsalicylate that is used to relieve symptoms of indigestion, heartburn, upset stomach, and diarrhea. Each 30 mL dose contains 525 mg of the active ingredient.

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 Bismuth subsalicylate. There are 12 other brand versions of Bismuth subsalicylate.

What is the NDC code for Soothe 525 mg/30mL?

The NDC (National Drug Code) for Soothe 525 mg/30mL is 0363-7240, listed by Walgreens.

Product NDC

0363-7240

Package NDC

0363-7240-08

Other Bismuth Brands

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

Data from openFDA · Public domain (CC0 1.0)