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Virtussin AC

Dosage form: liquid
Ingredients: CODEINE PHOSPHATE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Virtus Pharmaceuticals LLC
NDC code: 76439-252

Virtussin A/C

Drug Facts

Active ingredients
(in each teaspoonful (5 mL))		Purpose
Codeine Phosphate USP 10 mgAntitussive
Guaifenesin USP 100 mgExpectorant

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. 09/13

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 76439-252-16

Virtussin
A/C

Antitussive
Expectorant

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate USP10 mg
Guaifenesin USP100 mg

16 fl. oz. (473 mL)

VIRTUSSIN AC 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76439-252
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76439-252-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/11/2013
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 12/2013
Document Id: 1f7db699-8b83-450e-8ff8-c44f3247e1a3
Set id: 1f7db699-8b83-450e-8ff8-c44f3247e1a3
Version: 1
Effective Time: 20131211
 
Virtus Pharmaceuticals LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer