Tussin Cf

Tussin Cf
SPL v1
SPL
SPL Set ID d92289f4-1434-4b03-bce0-c6acae1d64ae
Route
ORAL
Published
Effective Date 2014-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Sucralose Fd&c Red No. 40 Propylene Glycol Glycerin Sodium Citrate Menthol Water

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-10

Description

Active ingredients (in each 5 mL tsp): Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant Phenylephrine HCl, USP 5 mg Nasal decongestant


Medication Information

Description

Active ingredients (in each 5 mL tsp): Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant Phenylephrine HCl, USP 5 mg 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
Section 42229-5

Manufactured by:

davAgen

Pharmaceutical LLC


Somerset, NJ 08873

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center

Section 50566-9

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.

Section 50569-3

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 5 mL tsp): Purpose
Dextromethorphan HBr, USP 10 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Phenylephrine HCl, USP 5 mg Nasal decongestant
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
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
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.
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

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)


Structured Label Content

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
Section 42229-5 (42229-5)

Manufactured by:

davAgen

Pharmaceutical LLC


Somerset, NJ 08873

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL tsp): Purpose
Dextromethorphan HBr, USP 10 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Phenylephrine HCl, USP 5 mg Nasal decongestant
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
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
Do Not Use (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.
Other Information (Other information)

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

Dosage cup provided.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 237 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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