FDA Label for Igualtuss
View Indications, Usage & Precautions
Igualtuss Product Label
The following document was submitted to the FDA by the labeler of this product Alternative Pharmacal 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.
Otc - Active Ingredient
Active Ingredients (in each 5 mL tsp.) Purpose
Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant
Guaifenesin .............................. 388 mg ................ Expectorant
Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Warnings
Warnings
- Do not exceed recommended dosage
- A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reccur or is accompanied by a fever, rash or persistent headache, consult a doctor
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
When using this product, do not exceed recommended dosage
Otc - Do Not Use
Do not use
- For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
- If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by doctor
- if you are now 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargment of the prostate gland unless directed by a doctor.
If you have
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.
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
- temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation ocurring with the common cold or inhaled irritants.
Dosage & Administration
Directions Do not exceed more than 6 doses in any 24-hour period
Adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of age ask a doctor
Inactive Ingredient
Inactive ingredients: Citric acid, FD&C Yellow #6, flavor, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, glycerine and sucralose
Otc - Questions
Questions or comments? 1-786-507-1566
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