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Coditussin AC

Medically reviewed on May 10, 2018.

Dosage form: syrup
Ingredients: CODEINE PHOSPHATE 10mg in 5mL, GUAIFENESIN 200mg in 5mL
Labeler: Glendale Inc
NDC Code: 70147-313

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.

Coditussin AC

Drug Facts

Active ingredients (in each teaspoonful)Purpose
(Warning: May be habit-forming)
Codeine Phosphate 10 mgAntitussive (cough suppressant)
Guaifenesin 200 mgExpectorant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition
  • new symptoms occur
  • product may cause or aggravate constipation

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.

Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Adults and children 12 years of age and over:2 teaspoonfuls every 4 hours, not to exceed 12 teaspoons in 24 hours
Children 6 to under 12 years of age:1 teaspoonful every 4 hours, not to exceed 6 teaspoons in 24 hours
Children under 6 years of age:Consult a doctor

Other information

Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

To report a serious adverse event or obtain product information, Call 1-630-530-7000.

Distributed by:

Glendale Inc

Villa Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 70147-616-16

Coditussin
AC

Expectorant
Cough Suppressant

CV

Each teaspoonful for oral
administration contains:

Codeine Phosphate* 10 mg
*(Warning: May be habit-forming)

Guaifenesin 200 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Cotton Candy Flavored Liquid

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

Distributed by:

Glendale Inc

Villa Park, IL 60181

16 fl oz. (473 mL)

CODITUSSIN AC 
codeine phosphate and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-313
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE, UNSPECIFIED FORM 
SORBITOL 
GLYCERIN 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70147-313-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2016
Labeler - Glendale Inc (079987961)

 
Glendale Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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