FDA Label for Tussin Cf

View Indications, Usage & Precautions

Tussin Cf Product Label

The following document was submitted to the FDA by the labeler of this product Davagen Pharmaceutical, Llc. 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 - Purpose



Active ingredients (in each 5 mL tsp):Purpose
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant
Phenylephrine HCl, USP 5 mgNasal 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

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.

Otc - Ask Doctor



Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, trouble urinating due to an enlarged prostate gland

Do not exceed recommended dose


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


Other Information



Each tsp contains: sodium 6 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.


Inactive Ingredients



citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose


Directions



do not take more than 6 doses in any 24-hour period

  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter; tsp = teaspoonful
  • agedose
    adults and children 12 years and over10 mL (2 tsp) every 4 hours
    children under 12 yearsdo not use

Other



Manufactured by:
davAgen
Pharmaceutical LLC

Somerset, NJ 08873


Principal Display Panel - 237 Ml Bottle Label



davAgen
pharmaceutical

NDC 76140-105-08

Adults & Children Ages 12 & Older

Tussin CF

Cough & Cold

Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl

For Relief of:

* Please review the disclaimer below.