Coditussin AC

Label at a glance#

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each teaspoonful)	Purpose
Codeine Phosphate* 10 mg	Antitussive (cough suppressant)
Guaifenesin 200 mg	Expectorant

* (Warning: May be habit-forming)

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

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

* Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

Glendale Inc

Villa Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Coditussin AC
• CODEINE PHOSPHATE and GUAIFENESIN
• CODEINE PHOSPHATE
• CODEINE ANHYDROUS
• GUAIFENESIN
• CITRIC ACID MONOHYDRATE
• PROPYLENE GLYCOL
• WATER
• SACCHARIN SODIUM
• SODIUM CITRATE, UNSPECIFIED FORM
• SORBITOL
• GLYCERIN

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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Adverse event summaries are temporarily unavailable. Other product information remains available.