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  5. Label Information: Sugar Free Mountain Herb Cough Suppressant Throat Drops

FDA Label for Sugar Free Mountain Herb Cough Suppressant Throat 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. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sugar Free Mountain Herb Cough Suppressant Throat Drops Product Label

The following document was submitted to the FDA by the labeler of this product Ricola Usa Inc.. 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 anesthetic


Active Ingredient (In Each Drop)



Menthol, 4.8 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 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor

Other Information



  • Phenylketonurics: contains phenylalanine 1 mg per drop
  • excessive use may have a laxative effect
  • store in a dry place
  • product may be useful for diabetics on the advice of a doctor

    • Exchange information:   2 Drops = FREE Exchange

                                                    7 Drops = 1 Fruit

    Dietary exchanges based on Exchange Lists for Diabetics

    © 2008 American Diabetes Association, American Dietetic Association


Inactive Ingredients



aspartame, color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, sorbitol


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