SOOTHE CHEWABLE- citric acid chewable gel

Soothe Chewable by

Drug Labeling and Warnings

Soothe Chewable by is a Otc medication manufactured, distributed, or labeled by Carolina Cannabis Creations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each chewable)

Citric Acid 75mg

Purpose

Antacid

Uses

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

Warnings

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

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

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

Stop using and ask a doctor if

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

If pregnant or breast-feeding

consult a health professional before use

Keep out of reach of children

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

Keep out of reach of children

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

Directions

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

Store at 68-77 degrees F

Avoid direct sunlight

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHE CHEWABLE 
citric acid chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-843
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1.5 g  in 108.27 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)	34.9 g  in 108.27 g
SORBITOL (UNII: 506T60A25R)	2.9 g  in 108.27 g
GELATIN (UNII: 2G86QN327L)	6.78 g  in 108.27 g
.DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)- (UNII: ZHX2VN2N5R)	0.575 g  in 108.27 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 g  in 108.27 g
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)	0.12 g  in 108.27 g
CORN SYRUP (UNII: 9G5L16BK6N)	33.9 g  in 108.27 g
WATER (UNII: 059QF0KO0R)	27.75 g  in 108.27 g

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-843-20	108.27 g in 1 BAG; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	08/01/2023

Labeler - Carolina Cannabis Creations LLC (118697474)

Registrant - Carolina Cannabis Creations LLC (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Carolina Cannabis Creations LLC		118697474	manufacture(82876-843)