VIRTUSSIN AC- codeine phosphate and guaifenesin liquid 
Preferred Pharmaceuticals, Inc.

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.

----------

Virtussin A/C

Drug Facts

Active ingredients
(in each teaspoonful (5 mL))

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 makes cough 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).

Inactive ingredients

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

Manufactured for: Virtus Pharmaceuticals, LLC
Tampa, FL 33619

Rev. 01/2014

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 68788-9225-1

Virtussin
A/C

Antitussive/Expectorant

Each 5 mL (1 teaspoonful) contains:

Codeine phosphate USP

10 mg

Guaifenesin USP

100 mg

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

4 fl. oz. (118 mL)

Relabeled By: Preferred Pharmaceuticals Inc.

Virtussin AC Liquid (CV)
VIRTUSSIN AC 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9225(NDC:76439-252)
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
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:68788-9225-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/201412/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/06/201412/27/2017
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9225)

Revised: 12/2017
Document Id: 05066d86-e64d-42d6-8f56-e2a1cb8e5fde
Set id: fe6ed22b-f41f-4fae-9092-6c1253e09bd6
Version: 3
Effective Time: 20171227
 
Preferred Pharmaceuticals, Inc.