Label: KOFIX CHERRY AND BLACKBERRY- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 82340-002-04, 82340-002-24 - Packager: Global Health Solution 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 January 7, 2022
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredient (in each lozenge)
- Purpose
- Uses
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Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by physician
Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
• sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsensIf pregnant or breast-feeding, ask a health professional before use.
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INGREDIENTS AND APPEARANCE
KOFIX CHERRY AND BLACKBERRY
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82340-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 8 mg Inactive Ingredients Ingredient Name Strength ANETHOLE (UNII: Q3JEK5DO4K) BLACK CURRANT JUICE (UNII: 9L8NK01P32) CARMINIC ACID (UNII: CID8Z8N95N) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CLOVE OIL (UNII: 578389D6D0) STARCH, CORN (UNII: O8232NY3SJ) EUCALYPTUS OIL (UNII: 2R04ONI662) ACACIA (UNII: 5C5403N26O) SUCROSE (UNII: C151H8M554) Product Characteristics Color red Score no score Shape ROUND Size 19mm Flavor CHERRY, BLACKBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82340-002-24 2 in 1 BOX 11/01/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:82340-002-04 1 in 1 BOX 01/06/2022 2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2021 Labeler - Global Health Solution LLC (117922627)