FDA Label for Ritussin Expectorant

View Indications, Usage & Precautions

Ritussin Expectorant Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. 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.

Active Ingredient (In Each 5 Ml)(One Teaspoonful)



Guaifenesin, USP 100 mg


Purpose



Expectorant


Use



helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Otc - Ask Doctor



Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • do not take more than 6 doses in any 24-hour period
  • agedose
    adults and children 12 years of age and over2-4 teaspoons every 4 hours
    children 6 years to under 12 years of age1-2 teaspoonful every 4 hours
    children 2 years to under 6 years of age1/2-1 teaspoonful every 4 hours
    children under 2 years of ageask a doctor

Other Information



  • •store at room temperature 15° - 30°C (59° - 86°F)
  • •protect from freezing.
  • •protect from light.
  • •Each teaspoon (5 mL) contains: sodium 2 mg.
  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive Ingredients



caramel, citric acid, FD&C Red #40, , flavors, glucose, glycerin, high fructose corn syrup, menthol, propylene glycol, sodium saccharin, sodium benzoate, water


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