Other
Drug Facts
Distributed by:
Glendale Inc
Villa Park, IL 60181
Coditussin Ac
FDA Label NDC 70147-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glendale Inc for the product Coditussin Ac (NDC 70147-313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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)
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
