Label: SOOTHE CHEWABLE- citric acid chewable gel
- NDC Code(s): 82876-840-20
- Packager: Carolina Cannabis Creations LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each chewable)
- Uses
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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
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOOTHE CHEWABLE
citric acid chewable gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82876-840 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 SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE) 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 green Score Shape Size Flavor WATERMELON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82876-840-20 108.27 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(82876-840)
