Label: HONEY LEMON COUGH DROP- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL

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 August 12, 2016

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 7.5mg

  • PURPOSE

    Purpose

    Cough suppressant/

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses temporarily relieves:

    • cough as may occur with a cold
    • occasional minor irritation and sore throat
  • WARNINGS

    Sore throat warning: if sore throat is severs, persists for

    more than 2 days, is accompanied or followed by fever,

    headaches, rash, swelling, nausea, or vomiting, consult a

    doctor promptly. If sore mouth symptoms do not improve

    ub 7 days, see your dentist or doctor promptly. These

    symptoms may be serious.

  • ASK DOCTOR

    Ask a doctor before use if you have:

    • persistent or chronic chough such as occurs with

    smoking, asthma, or emphysema

    • cough accompanied by excessive phlegm (mucus)
  • ASK DOCTOR

    Stop use and ack doctor if

    • cough persists for more than 7 day, tends to recur, or

    is accompanied by fever, rash, or persistent headache.

    These could be signs of a serious condition.

    • sore throat is severe, or irritation, pain or redness lasts

    or worsens

    • sore mouth does not improve in 7 days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional

    before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 5 years and over

    dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor

    children under 5 years ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information 10 calories per drop

  • INACTIVE INGREDIENT

    Inactive ingredients: Beta carotene (color), conr

    starch, corn syrup, eucalyptus oil, glycerin, honey, medium

    chain triglycerides, natural & artificial flavors, soybean

    oil, sucrose and water

  • QUESTIONS

    Questions? Call (888) 309-9030.

  • PRINCIPAL DISPLAY PANEL

    HEB Honey Lemon 30ct

  • INGREDIENTS AND APPEARANCE
    HONEY LEMON COUGH DROP 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-034
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeOVALSize17mm
    FlavorHONEYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-034-3030 in 1 BAG; Type 0: Not a Combination Product05/15/2013
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/15/2013
    Labeler - HEB (007924756)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(37808-034)
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