VIRTUSSIN A/C- codeine phosphate and guaifenesin liquid

Virtussin A/C by

Drug Labeling and Warnings

Virtussin A/C by is a Otc medication manufactured, distributed, or labeled by Unit Dose Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL = 1 tsp)	Purpose
Codeine phosphate, USP 10 mg	Antitussive
Guaifenesin, USP 100 mg	Expectorant

Uses

• 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.

Warnings

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.

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.

Directions

• 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.

Inactive ingredients

Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

HOW SUPPLIED

Product: 50436-2520

NDC: 50436-2520-1 118 mL in a BOTTLE

VIRTUSSIN A/C (CODEINE PHOSPHATE AND GUAIFENESIN) LIQUID

INGREDIENTS AND APPEARANCE

VIRTUSSIN A/C 
codeine phosphate and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50436-2520(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: 50436-2520-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/07/2015

Labeler - Unit Dose Services (831995316)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Services		831995316	REPACK(50436-2520) , RELABEL(50436-2520)