Carolina Cannabis Relaxation Chewables Orange

Carolina Cannabis Relaxation Chewables by

Drug Labeling and Warnings

Carolina Cannabis Relaxation Chewables by is a Homeopathic medication manufactured, distributed, or labeled by Carolina Cannabis Creations L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAROLINA CANNABIS RELAXATION CHEWABLES- withania somnifera chewable gel 
Carolina Cannabis Creations L.L.C

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Carolina Cannabis Relaxation Chewables Orange

Active Ingredients (In each chewable)

Ashwagandha root......15mg

Purpose

Ashwagandha 15mg.................Promotes Relaxation

Uses

Temporary relief from symptoms associated with, Anxiousness, nervousness, restlessness, and stress

Warnings

Ask a doctor before use if you are, taking a perscription drug

when using this product

avoid alcohol, use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Symptoms persist

Stop use and ask doctor if

Symptoms persist

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 posion 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 and over: take 1 chewable and repeat every 8-12 hours or as needed

do not swallow whole

do not take more than 4 times in a 24 hour period

Directions

Adults 18 years and over: take 1 chewable and repeat every 8-12 hours or as needed

Do not swallow whole

Do not take more than 4 times in a 24 hour period

Other information

Store at 20-25 degrees C (68-77 degrees F)

Avoid direct sunlight

Inactive ingredients

Sucrose, Light corn syrup, Aqua, Gelatin, Sorbitol, Citric acid, Natural flavors, Delta-8 Tetrahydrocannabinol, Potassium sorbate.

Jar label

Top label

CAROLINA CANNABIS RELAXATION CHEWABLES 
withania somnifera chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-803
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) (WITHANIA SOMNIFERA ROOT - UNII:V038D626IF)	WITHANIA SOMNIFERA ROOT	0.3 g  in 108.27 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)	34.9 g  in 108.27 g
CORN SYRUP (UNII: 9G5L16BK6N)	34.9 g  in 108.27 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1.5 g  in 108.27 g
SORBITOL (UNII: 506T60A25R)	2.9 g  in 108.27 g
WATER (UNII: 059QF0KO0R)	26.215 g  in 108.27 g
.DELTA.8-TETRAHYDROCANNABINOL (UNII: B49D0HH807)	0.575 g  in 108.27 g
GELATIN (UNII: 2G86QN327L)	6.78 g  in 108.27 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 g  in 108.27 g

Product Characteristics
Color	orange	Score
Shape	SQUARE	Size
Flavor	ORANGE (Natural Orange flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-803-40	108.27 g in 1 JAR; Type 0: Not a Combination Product	02/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/06/2023	07/31/2023

Labeler - Carolina Cannabis Creations L.L.C (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Carolina Cannabis Creations L.L.C		118697474	manufacture(82876-803)

Revised: 7/2023

Document Id: 01ccbd5d-c8aa-e3c5-e063-6394a90adbe4

34390-5

Set id: f60680c0-44c7-5734-e053-2995a90a0031

Version: 2

Effective Time: 20230731