CODITUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride syrup 
Glendale 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.

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Coditussin DAC

Drug Facts

Active ingredients (in each teaspoonful) Purpose
*
(Warning: May be habit-forming)
Codeine Phosphate* 10 mg Antitussive (cough suppressant)
Guaifenesin 200 mg Expectorant
PseudoephedrineHydrochloride 30 mg Nasal Decongestant

Uses

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

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis 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

When using this product

  • may cause or aggravate constipation

Stop use and ask a doctor if

  • cough or nasal congestion 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
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

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

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 2 teaspoonfuls every 4 to 6 hours, not to exceed 8 teaspoons in a 24 hour period
Children 6 to under 12 years of age: 1 teaspoonfuls every 4 to 6 hours, not to exceed 8 teaspoons in a 24 hour period
*Children under 6 years of age: Consult a doctor

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

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

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, 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 70147-414-16

Coditussin
DAC

Expectorant
Cough Suppressant
Nasal Decongestant

CV

Each teaspoonful for oral
administration contains:

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

Guaifenesin 200 mg

Pseudoephedrine HCl 30 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE / GLUTEN FREE

Grape 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)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
CODITUSSIN DAC 
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70147-414
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:70147-414-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 05/01/2016
Labeler - Glendale Inc (079987961)

Revised: 5/2016
Document Id: 5a3c4507-724c-4145-8d32-be791e9c6fa4
Set id: 99f53fa4-98e0-4f0c-9bb2-4c7163f841ec
Version: 1
Effective Time: 20160510
 
Glendale Inc