The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn Inc. for the product Goodsense Tussin Cf Multi-symptom Cold, Raspberry (NDC 50804-256). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 5 mL or 1 teaspoon) Purposes
Dextromethorphan HBr, 10 mg........................................................ Cough Suppressant
Guaifenesin, 100 mg................................................................................... Expectorant
Phenylephrine HCI, 5 mg................................................................ Nasal Decongestant
Purposes
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold:
• nasal congestion • cough due to minor throat and bronchial irritation
Warnings
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 • heart disease • high blood pressure
• thyroid disease • diabete s • trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic
such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are taking any other oral nasal
decongestant or stimulant.
Do not exceed recommended dosage.
Stop use and ask a doctor if • you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever • cough lasts
more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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 • this adult
strength product is not intended for use in children under 12 years of age • measure
only with dosing cup provided • keep dosing cup with product • TSP= teaspoon
| age | dose |
| adults and children 12 years and over | 2 teaspoons (10 mL) every 4 hours |
| children under 12 years | do not use |
Other information
•
each teaspoon (5mL) contains: sodium 3 mg
• store at 15-30°C (59-86°F ). Do not refrigerate.
Inactive ingredients anhydrous citric acid, FD&C red #40, glycerin, propylene
glycol, purified water, raspberry flavor, sodium benzoate, sorbitol solution, sucralose
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