Label: VIRTUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid
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- NDC Code(s): 69543-253-04
- Packager: Virtus Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 31, 2019
If you are a consumer or patient please visit this version.
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- Drug Facts
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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
- Uses
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- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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- temporarily relieves nasal congestion due to the common cold
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- temporarily restores freer breathing through the nose
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- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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- calms the cough control center and relieves coughing
- Warnings
Ask your doctor before use if you have
- ▪
- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to enlarged prostate gland
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- cough that occurs with excessive phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Do not use
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- in a child under 2 years of age
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- 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.
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- if you or your child has a chronic pulmonary disease or shortness of breath
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- if your child is taking other drugs, unless directed by a doctor
- When using this product
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- do not use more than directed
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- may cause drowsiness
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- constipation may occur or be aggravated
- Stop use and ask a doctor if
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- you get nervous, dizzy, or have trouble sleeping
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- 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
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.
Close - Directions
- ▪
- do not exceed 4 doses in any 24 hour period.
- 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.
- 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.
- Other information
Each tsp (5 mL) contains 3 mg sodium.
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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. - 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.
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Manufactured for:
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Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593
Rev. 11/2018
Made in USA
7269-0004 - Principal Display Panel – 118 mL Bottle Label
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NDC: 69543-253-04
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.
4 fl. oz. (118 mL)
VIRTUS®
PHARMACEUTICALS - INGREDIENTS AND APPEARANCE
VIRTUSSIN DAC
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69543-253 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CARAMEL, CHERRY, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69543-253-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/31/2019 CloseLabeler - Virtus Pharmaceuticals (079659493)