OLBAS PASTILLES (MENTHOL) PASTILLE [G. R. LANE HEALTH PRODUCTS LIMITED]

OLBAS PASTILLES (MENTHOL) PASTILLE [G. R. LANE HEALTH PRODUCTS LIMITED]
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NDC 59342-5003-1
Set ID 143b01b4-8e0d-48de-8876-bc94360dc162
Category HUMAN OTC DRUG LABEL
Packager G. R. Lane Health Products Limited
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient (in each drop)                                                     Purposes

    Menthol 10 mg  ...................  Antitussive, Cough Suppressant, Oral Anesthetic

  • PURPOSE

    Uses

    Temporarily relieves:

    • Cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
    • Occasional minor irritation or sore throat
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Olbas Pastilles

    Maximum Strength Herbal Cough Drops

    Powerful Vapors

    Extra Strong and Penetrating

    27 Pastilles

    Clears the Head

    Soothes the Throat

    Provides instant, cool soothing relief for sore throats and fights coughs. Powerful, cooling vapors help your nasal passages feel clearer, too! An effective formula made from soothing herbs and chlorophyll, which gives Olbas Pastilles their luscious green color - and helps freshen your breath, too!

  • WARNINGS

    Warnings

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomitine, consult a doctor promptly; these may be serious.

    Ask a doctor before use if you have:

    • persistent or chronic cough as occurs with smoking, asthma, or emphysema
    • cough that occurs with excessive phlegm (mucus)

    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.  These could be signs of a serious condition.
    • sore mouth symptoms do not improve in 7 days.

    If pregnant or breast-feeding, ask a health professional beofre use. 

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 3 years and over: allow 1 pastille to dissolve slowly in the mouth. Repeat every hour as needed, or as directed by a doctor. 
    • children under 3 years: ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients: chlorophyll, clove oil, eucalyptus oil, glucose, juniper berry oil, modified starch, sucrose, wintergreen oil.

  • OTHER SAFETY INFORMATION

    MFG in England by: G. R. Lane Health Products Ltd. Gloucester

    Imported and Dist by: Penn Herb Co, Ltd., Phila PA 19154

    www.Olbas.com

  • PRINCIPAL DISPLAY PANEL

    labellabel image

  • INGREDIENTS AND APPEARANCE
    OLBAS PASTILLES 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59342-5003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (Sodium Copper Chlorophyllin) Scoreno score
    ShapeOVAL (Pastille) Size17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59342-5003-127 in 1 BOX; Type 0: Not a Combination Product09/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/24/2010
    Labeler - G. R. Lane Health Products Limited (217362532)

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