Active Ingredients (In Each 10 Ml)
Dextromethorphan HBrDextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCI, USP 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Tussin Cf (NDC 70677-1187). 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 active ingredients (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Dextromethorphan HBrDextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCI, USP 10 mg
Cough suppressant
Expectorant
Nasal decongestant
■ 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.
■ 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.
■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes
■ trouble urinating due to 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.
taking any other oral nasal decongestant or stimulant.
When using this product do not use more than directed.
■ 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 persistent headache. These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
■ mL = milliliter
■ 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
| AGE | DOSE |
| Adults and children 12 years and over
| 10 mL every 4 hours
|
| Children under 12 years
| do not use
|
■ each 10 mL contains: sodium 6 mg
■ store at 20-25°C (68-77°F) ■ do not refrigerate
■ Keep carton for full Direction for use
anhydrous citric acid, FD&C red no.40, glycerin, menthol, natural & artificial flavor, propylene glycol,purified water, sodium benzoate, sorbitol solution, sucralose
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Distributed by:McKesson Corp., via Strategic Sourcing Services LLC.
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*This product is not manufactured or distributed by Pfizer,
owner of the registered trademark Robitussin
®
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