Tussin Cf
FDA Label NDC 76140-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Davagen Pharmaceutical, Llc for the product Tussin Cf (NDC 76140-105). 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 - purpose, uses, do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

  • Stuffy Nose
  • Cough
  • Chest Congestion & Mucus

    • 8 FL OZ (237 mL)

    Principal Display Panel (237 mL Bottle Label)

    Principal Display Panel (237 mL Bottle Label)

* Please review the disclaimer below.