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  5. Label Information: Coditussin Dac

FDA Label for Coditussin Dac

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS? COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Coditussin Dac Product Label

The following document was submitted to the FDA by the labeler of this product Glendale Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
Glendale Inc
Villa Park, IL 60181


Otc - Purpose



Active ingredients (in each teaspoonful)Purpose
Codeine Phosphate

(Warning: May be habit-forming)

10 mg		Antitussive (cough suppressant)
Guaifenesin 200 mgExpectorant
PseudoephedrineHydrochloride 30 mgNasal Decongestant

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
  • reduces swelling of nasal passages

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, 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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.


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 01

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - coditussin 01


* Please review the disclaimer below.