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  5. Label Information: Childrens Tussin Dm

FDA Label for Childrens Tussin Dm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. HOW SUPPLIED

Childrens Tussin Dm Product Label

The following document was submitted to the FDA by the labeler of this product Kingston Pharma Llc. 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.

Otc - Active Ingredient



Active Ingredient: Active Ingredient: Dextromethorphan HBr 5mg, Guaifenesin 100mg (in each 5 mL)


Otc - Purpose



Purpose:
Cough suppressant
Expectorant


Indications & Usage



  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to coughs more productive

Warnings



DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING

Warnings:


Otc - Do Not Use



Do not use if a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


Otc - Ask Doctor



Ask a doctor before use if the child has

  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with asthma

Otc - When Using



Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children. In case of overdose, seek professional assistance or contact a Poison control center right away.


Otc - Pregnancy Or Breast Feeding




Dosage & Administration



Directions:

  • This product does not contain directions or complete warnings for adult use.
  • Use only enclosed dosing cup provided.
  • Do not take more than 6 doses in any 24-hour period.
  • Children 6 years to under 12 years: 5 mL – 10 mL taken every 4 hours.
  • Children 4 years to under 6 years: 2.5 mL – 5 mL taken every 4 hours.
  • Children under 4 years: do not use.

Storage And Handling



Other information

  • each teaspoon contains: sodium 4 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredient



Inactive ingredients
Anhydrous citric acid, Artificial & Natural flavors, FD&C Blue#1, FD&C red 40, Sucralose, Glycerin, Polyethylen Glycol, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Benzoate


How Supplied



(packs: 4oz) Kingston NDC# 71027-036-04

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662


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