Heartburn
Heartburn is an FDA drug label for the active ingredient GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN manufactured by Forces of Nature administered by SUBLINGUAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260505.
- Generic name
- GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN
- Manufacturer
- Forces of Nature
- Product type
- HUMAN OTC DRUG
- Route
- SUBLINGUAL
- Dosage form
- N/A
- NDC
- 51393-5005
- Application
- N/A
- Label effective
- 20260505
About this product
Heartburn is an FDA-registered drug product whose active ingredient is GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN. It is labelled by Forces of Nature taken by sublingual and marketed as a human otc drug product. Identifiers on file: NDC 51393-5005, label effective 20260505. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN are most often described in connection with: help calm, occasional acid, indigestion upset, stomach heartburn. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses to help calm occasional acid indigestion, upset stomach, heartburn.
Dosage & Administration
Directions Shake well before use. For best results, use at the first sign of symptoms of acid reflux or heartburn. Place 6 - 9 drops under the tongue. Repeat as needed.
Warnings
Warnings For oral (sublingual) use. Children under 12 years of age: consult a doctor. Stop use and ask doctor if symptoms persist for more than 3 days or worsen. In case of bleeding, consult a doctor promptly. If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0438-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 | NATCO Pharma Limited | Class II | Terminated | 20240417 |
| D-0793-2019 | Dr. King's SafeCare Rx Heartburn Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955002222, NDC 57955-0022-2 | King Bio Inc. | Class I | Terminated | 20190320 |
| D-0532-2019 | Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955502227, NDC 57955-5022-2 | King Bio Inc. | Class I | Terminated | 20190320 |
| D-1134-2015 | Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2. | Allegiant Health | Class II | Terminated | 20150624 |
| D-884-2013 | Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34 | Dr. Reddy's Laboratories, Inc. | Class II | Terminated | 20130821 |
Frequently asked questions
What is Heartburn used for?
Uses to help calm occasional acid indigestion, upset stomach, heartburn.
Who makes Heartburn?
Forces of Nature is the labeler of record for Heartburn.
What form does Heartburn come in?
administered by sublingual. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Heartburn prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Heartburn been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.