Label: VIRTUSSIN A/C- codeine phosphate and guaifenesin liquid
- NDC Code(s): 69543-252-04, 69543-252-16
- 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.
Updated November 3, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- your cough to help you sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
- temporarily relieves:
Ask your doctor before use if
- you have a persistent cough, this may be a sign of a serious condition
- you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- you have a cough that is accompanied by excessive phlegm (mucus)
- you have chronic pulmonary disease or shortness of breath
- giving to a child who is taking other drugs
When using this product
- giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
- may cause or aggravate constipation
Stop use and ask a doctor if
- symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- do not exceed 6 doses in 24 hours.
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.
- Other information
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.Close
- Inactive ingredients
Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.Close
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
ALCOHOL-FREE / SUGAR-FREE
Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 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)
- INGREDIENTS AND APPEARANCE
codeine phosphate and guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69543-252 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 Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) methylparaben (UNII: A2I8C7HI9T) potassium citrate (UNII: EE90ONI6FF) potassium sorbate (UNII: 1VPU26JZZ4) propylparaben (UNII: Z8IX2SC1OH) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69543-252-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2015 2 NDC:69543-252-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/07/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/07/2015 Labeler - Virtus Pharmaceuticals (079659493)