Virtussin DAC Codeine phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride Codeine phosphate Codeine Anhydrous Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine Alcohol citric acid monohydrate FD&C red no. 40 glycerin potassium citrate propylene glycol water sodium benzoate saccharin sodium sorbitol Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves nasal congestion due to the common cold • temporarily restores freer breathing through the nose • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • calms the cough control center and relieves coughing

Virtussin DAC Codeine phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride Codeine phosphate Codeine Anhydrous Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine Alcohol citric acid monohydrate FD&C red no. 40 glycerin potassium citrate propylene glycol water sodium benzoate saccharin sodium sorbitol

Mfr: OTC
FunFoxMeds bottle

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate USP 10 mg Cough Suppressant Guaifenesin USP 100 mg Expectorant Pseudoephedrine HCl USP 30 mg Nasal Decongestant
Inactive Ingredients
Inactive ingredients Alcohol caramel flavor cherry flavor citric acid FD&C red #40 glycerin menthol flavor potassium citrate propylene glycol purified water sodium benzoate sodium saccharin sorbitol 70% solution.
Strengths
5 ml 10 mg 100 mg 30 mg
Quantities
473 ml 5 ml
Treats Conditions
Uses Temporarily Relieves Cough Due To Minor Throat And Bronchial Irritation As May Occur With A Cold Temporarily Relieves Nasal Congestion Due To The Common Cold Temporarily Restores Freer Breathing Through The Nose Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Make Coughs More Productive Calms The Cough Control Center And Relieves Coughing

Identifiers & Packaging

Container Type BOTTLE
Packaging

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS PHARMACEUTICALS NDC: 69543 -253- 16 Virtussin DAC Cough Suppressant Expectorant Nasal Decongestant CV SUGAR FREE • 2.1% (v/v) ALCOHOL Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg Pseudoephedrine HCl, USP 30 mg (WARNING: May be habit-forming) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS PHARMACEUTICALS NDC: 69543 -253- 16 Virtussin DAC Cough Suppressant Expectorant Nasal Decongestant CV SUGAR FREE • 2.1% (v/v) ALCOHOL Each 5 mL (1 teaspoonful) contains: Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg Pseudoephedrine HCl, USP 30 mg (WARNING: May be habit-forming) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Overview

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves nasal congestion due to the common cold • temporarily restores freer breathing through the nose • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • calms the cough control center and relieves coughing

Indications & Usage

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves nasal congestion due to the common cold • temporarily restores freer breathing through the nose • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • calms the cough control center and relieves coughing

Dosage & Administration

Directions • do not exceed 4 doses in any 24 hour period. Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Warnings & Precautions
Warnings Ask your doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to enlarged prostate gland • cough that occurs with excessive phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Do not use • in a child under 2 years of age • 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. • if you or your child has a chronic pulmonary disease or shortness of breath • if your child is taking other drugs, unless directed by a doctor When using this product • do not use more than directed • may cause drowsiness • constipation may occur or be aggravated Stop use and ask a doctor if • you get nervous, dizzy, or have trouble sleeping • 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Pseudoephedrine HCl, USP 30 mg Nasal Decongestant

Do Not Use

Do not use • in a child under 2 years of age • 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. • if you or your child has a chronic pulmonary disease or shortness of breath • if your child is taking other drugs, unless directed by a doctor

When Using

When using this product • do not use more than directed • may cause drowsiness • constipation may occur or be aggravated

Stop Use & Ask a Doctor

Stop use and ask a doctor if • you get nervous, dizzy, or have trouble sleeping • 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.

Keep Out of Reach of Children

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

Storage & Handling

Other information Each tsp (5 mL) contains 3 mg sodium. Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.


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