Label: MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS- menthol lozenge
- NDC Code(s): 61658-110-30, 61658-110-80
- Packager: YUNNAN BAIYAO GROUP CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 7, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each lozenge)
- Purposes
- Uses
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Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough 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 mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens - Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
RESEALABLE BAG
COMPARE TO ACTIVE INGREDIENT OF HALLS®
MENTHOL FLAVOR
√ SOOTHING DROPS
√ GLUTEN FREE
√ DAIRY FREECLOSE BAG TO MAINTAIN FRESHNESS
DISTRIBUTED BY:
MEDICAL GROUP CARE, LLC
NAPLES, FL 34110MADE IN CHINA
This product is not manufactured or distributed by
Intercontinental Great Brands LLC., owner of the registered trademark HALLS®Contains 12 calories per lozenge
customerservice@mgc.usCHOKING HAZARD:
• SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.
• CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING. - Packaging
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INGREDIENTS AND APPEARANCE
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61658-110 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 5.4 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CORN SYRUP (UNII: 9G5L16BK6N) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) SOYBEAN LECITHIN (UNII: 1DI56QDM62) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape OVAL Size 21mm Flavor MENTHOL Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61658-110-30 30 in 1 BAG; Type 0: Not a Combination Product 06/21/2024 2 NDC:61658-110-80 80 in 1 BAG; Type 0: Not a Combination Product 06/21/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/21/2024 Labeler - YUNNAN BAIYAO GROUP CO.,LTD (654223122)