Label: ADEA GARGLE- citric acid, sodium hydrogen carbonate, xylitol tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 72191-0100-1 - Packager: K2resource co., ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 26, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADEA GARGLE
citric acid, sodium hydrogen carbonate, xylitol tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72191-0100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 36.2 g in 100 mg XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL 5 g in 100 mg Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) Product Characteristics Color white Score score with uneven pieces Shape BULLET Size 17mm Flavor PEPPERMINT Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72191-0100-1 850 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2018 Labeler - K2resource co., ltd. (694503238) Registrant - K2resource co., ltd. (694503238) Establishment Name Address ID/FEI Business Operations K2resource co., ltd. 694503238 manufacture(72191-0100)