SOOTHE CHEWABLE- citric acid chewable gel 
Carolina Cannabis Creations LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Soothe Chewable Strawberry

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.

bag label

SOOTHE CHEWABLE 
citric acid chewable gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-841
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1.5 g  in 108.27 g
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82876-841-20108.27 g in 1 BAG; Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/01/2023
Labeler - Carolina Cannabis Creations LLC (118697474)
Registrant - Carolina Cannabis Creations LLC (118697474)
Establishment
NameAddressID/FEIBusiness Operations
Carolina Cannabis Creations LLC118697474manufacture(82876-841)

Revised: 9/2023
Document Id: 04a77d35-25c9-6092-e063-6294a90ae4c4
Set id: 04a78060-7f0d-c4bd-e063-6294a90ae152
Version: 1
Effective Time: 20230905
 
Carolina Cannabis Creations LLC