CERTUSS-D - chlophedianol hydrochloride, guaifenesin and pseudoephedrine hydrochloride tablet
Capellon Pharmaceuticals, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active Ingredients (per tablet)
Chlophedianol Hydrochloride 25 mg
Guaifenesin 400 mg
Pseudoephedrine Hydrochloride 60 mg
Purpose
Chlophedianol Hydrochloride Cough Suppressant
Guaifenesin Expectorant
Pseudoephedrine Hydrochloride Nasal Decongestant
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion reduces swelling of nasal passages.
Warnings
Do not exceed recommended dosage.
Do not use
- 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
- new symptoms occur
If pregnant or breast feeding
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
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Adults and children 12 years of age and over: take 1 tablet every 6 to 8 hours.
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Children 6 to under 12 years of age: take 1/2 tablet every 6 to 8 hours.
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Children under 6: consult a doctor.
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Do not exceed 4 doses in a 24 hour period or as directed by a doctor.
Other information
store at 20°-25°C (68°-77°F)
Inactive ingredients
calcium phosphate dibasic, colloidal silicon dioxide, crospovidone polyplasdone, D&C Red #30, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose
Questions or Comments?
Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Figure 1: 90 count label