FDA.reportPublic FDA data

Soothe Chewable

Manufacturer
Carolina Cannabis Creations LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:46

Label at a glance#

ProductSoothe Chewable
Active ingredientCITRIC ACID MONOHYDRATE
Label structure7 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

bag labelbag label

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-841-20Soothe Chewable108.27 g in 1 BAGCHEWABLE GEL108.272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82876-841SOOTHE CHEWABLE (CITRIC ACID) CHEWABLE GEL [CAROLINA CANNABIS CREATIONS LLC]2Current NDC, 1 package rows20250117_04a78060-7f0d-c4bd-e063-6294a90ae152.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82876-84182876-841-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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

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
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
ndc (package): 82876-841-20
ndc (product): 82876-841
ndc11 (package): 82876084120
spl id: 2bcab1d4-51f6-55ed-e063-6394a90a0229
spl set id: 04a78060-7f0d-c4bd-e063-6294a90ae152

Reported adverse events (FAERS/openFDA)#

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