CODITUSS DM- dextromethorphan hydrobromide and phenylephrine hydrochloride and pyrilamine maleate syrup 
Qualitest 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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CODITUSS DM

Active ingredients (in each 5 mL = 1 tsp)

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Pyrilamine maleate 8.33 mg

Purpose

Cough suppressant

Nasal decongestant

Antihistamine

Uses

  • temporarily suppresses cough associated with the common cold or inhaled irritant(s)  
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies  
  • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

Drug interaction precaution. 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis  
  • glaucoma 
  • difficulty urinating due to enlargement of the prostate gland 
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus)  
  • heart disease, high blood pressure, thyroid disease, or diabetes

Ask a doctor or a pharmacist before use if you are taking sedatives or tranquilizers.

Ask a doctor before giving to children who are taking other drugs.

When using this product

  • do not exceed recommended dosage 
  • you may get drowsy
  • alcohol, sedatives, and tranquilizers may increase drowsiness  
  • avoid alcoholic drinks  
  • be careful when driving a motor vehicle or operating machinery  
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur
  • cough persists for more than one week, tends to recur or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign of a serious condition.

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

Keep out of 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 and over 
2 teaspoonfuls every 4 hours,
or as directed by a physician 
children 6 years to
under 12 years
1 teaspoonful every 4 hours,
or as directed by a physician 
children under 6 years consult a physician 

Other information

Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

citric acid, flavor, menthol racemic, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Made in the USA
for Qualitest Pharmaceuticals
130 Vintage Drive
Huntsville, AL 35811

Rev. 2/15  R5
8062012  0728

PRINCIPAL DISPLAY PANEL

This is the front and back of the Codituss DM 4oz label
CODITUSS DM 
dextromethorphan hydrobromide and phenylephrine hydrochloride and pyrilamine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0728
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE8.33 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0728-54118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/199701/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/199701/31/2017
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0728)

Revised: 3/2015
 
Qualitest Pharmaceuticals