FDA.reportPublic FDA data

Earthmed Soothe Chewable Orange

Manufacturer
Earthmed LLC
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:16:06

Label at a glance#

ProductEarthmed Soothe Chewable Cherry
Active ingredientCITRIC ACID MONOHYDRATE
Label structure10 sections

Indications and uses

For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.

Dosage and administration

Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician Do not swallow whole

Label contents#

Full prescribing information#

Active ingredients (in each chewable)

OTC - ACTIVE INGREDIENT SECTION

Citric Acid 75mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.

Warnings

WARNINGS SECTION

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Do not use

OTC - DO NOT USE SECTION

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

Stop using and ask a doctor if

OTC - STOP USE SECTION

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose seek medical help or contact a poison control center right away

Keep out of reach of children

OVERDOSAGE SECTION

In case of overdose, seek medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician

Do not swallow whole

Other information

OTHER SAFETY INFORMATION

Store at 68-77 degrees F

Avoid direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Artificial flavors, Gelatin, Delta 8 Tetrahydrocannabinol, Light corn syrup, Potassium Sorbate, Sorbitol, Beta Vulgaris powder, Sugar, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strawberry bag labelStrawberry bag label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cherry bagcherry bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

watermelon bagwatermelon bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange bagOrange bag

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-981-20Earthmed Soothe Chewable Orange108.27 g in 1 BAGCHEWABLE GEL108.271
82876-982-20Earthmed Soothe Chewable Strawberry108.27 g in 1 BAGCHEWABLE GEL108.271
82876-983-20Earthmed Soothe Chewable Watermelon108.27 g in 1 BAGCHEWABLE GEL108.271
82876-984-20Earthmed Soothe Chewable Cherry108.27 g in 1 BAGCHEWABLE GEL108.271

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82876-98182876-981-20
82876-98282876-982-20
82876-98382876-983-20
82876-98482876-984-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
.DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)-ZHX2VN2N5RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6IACT
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
.DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)-ZHX2VN2N5RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6IACT
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
.DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)-ZHX2VN2N5RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6IACT
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
.DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)-ZHX2VN2N5RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDESN2UDM48ZD6IACT
CORN SYRUP9G5L16BK6NIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
ndc (package): 82876-982-20
ndc (package): 82876-983-20
ndc (package): 82876-984-20
ndc (package): 82876-981-20
ndc (product): 82876-981
ndc (product): 82876-983
ndc (product): 82876-982
ndc (product): 82876-984
ndc11 (package): 82876098420
ndc11 (package): 82876098120
ndc11 (package): 82876098320
ndc11 (package): 82876098220
spl id: 4395440d-5a64-b9c7-e063-6394a90ab4ac
spl set id: 439543fe-ceb9-4c5c-e063-6294a90a9b70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.