FDA Label for Coditussin Ac

View Indications, Usage & Precautions

OTHER
OTC - PURPOSE
USES
WARNINGS
DO NOT USE THIS PRODUCT
ASK A DOCTOR BEFORE USE IF YOU HAVE
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS? COMMENTS?
PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Coditussin Ac 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 mg	Expectorant

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

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

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

Principal Display Panel - 473 Ml Bottle Label

NDC 70147-616-16

Coditussin
AC

Expectorant
Cough Suppressant

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.