VIRTUSSIN AC- codeine phosphate and guaifenesin liquid 
Virtus Pharmaceuticals

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.

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Virtussin AC

Drug Facts

Active ingredients
(in each 5 mL = 1 tsp)
Purpose

Codeine phosphate, USP 10 mg

Cough suppressant

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.

Manufactured for: Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593
Made in USA

Rev. 07/2019
7270-0016

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 69543-252-16

Virtussin
AC

Cough Suppressant
Expectorant

CV

SUGAR FREE • DYE FREE
ALCOHOL 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)

VIRTUS®
PHARMACEUTICALS

473 mL Bottle Label
VIRTUSSIN AC 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69543-252
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine phosphate (UNII: GSL05Y1MN6) (Codeine anhydrous - UNII:UX6OWY2V7J) Codeine phosphate10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69543-252-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/201510/31/2022
2NDC:69543-252-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/201503/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/201503/31/2023
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 8/2022
 
Virtus Pharmaceuticals