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  5. Label Information: The Original Natural Herb Cough Drops

FDA Label for The Original Natural Herb Cough Drops

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH DROP)
    3. USES
    4. WARNINGS
    5. ASK DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The Original Natural Herb Cough Drops Product Label

The following document was submitted to the FDA by the labeler of this product Ricola Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Purpose

Cough suppressant, Oral pain reliever


Active Ingredient (In Each Drop)



Menthol, 5.3 mg


Uses



temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth

Warnings



Sore throat warnings:

  • 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.  These may be serious.
  • do not use in children under 6 years of age unless directed by a doctor.

Ask Doctor Before Use If You Have



  • persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by 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 does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children.





Directions



  • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor.
  • children under 6 years: ask a doctor

Inactive Ingredients



Color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural flavor, starch syrup, sugar

Package Label.Principal Display Panel



Image of STG_ETGD_RKZ_37G_US_9008618_Final.jpg - STG ETGD RKZ 37G US 9008618 Final

Image of STG_ETGD_RKZ_37G_US_9008618_Final.jpg - STG ETGD RKZ 37G US 9008618 Final


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