Label: XPECT HONEY LEMON COUGH DROPS- honey lemon cough drops lozenge
- NDC Code(s): 42961-233-01, 42961-233-02, 42961-233-03
- Packager: Cintas Corporation
- 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 July 20, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel - 42961-233-02
- Principal Display Panel - 42961-233-03
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INGREDIENTS AND APPEARANCE
XPECT HONEY LEMON COUGH DROPS
honey lemon cough drops lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-233 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9 mg Inactive Ingredients Ingredient Name Strength BETA CAROTENE (UNII: 01YAE03M7J) CORN SYRUP (UNII: 9G5L16BK6N) EUCALYPTUS OIL (UNII: 2R04ONI662) HONEY (UNII: Y9H1V576FH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape OVAL Size 17mm Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-233-02 50 in 1 BOX 07/20/2023 1 NDC:42961-233-01 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:42961-233-03 100 in 1 BOX 07/20/2023 2 NDC:42961-233-01 1 in 1 PACKET; 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 07/20/2023 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations Riclan S.A. 911989788 manufacture(42961-233)