FDA Label for Coricidin Hbp Cough And Cold
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- CARTON 16
Coricidin Hbp Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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
Otc - Active Ingredient
Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg………………………….....................Antihistamine
Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant
Indications & Usage
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves runny nose and sneezing due to the common cold
Warnings
Warnings
Otc - Do Not Use
Do not use
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Do not use to sedate children.
Otc - Ask Doctor
Ask a doctor before use if you have
- trouble urinating due to an enlarged prostate gland
- cough that occurs with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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 overdose, get medical help or contact
a Poison Control Center right away. Abuse of this product can lead to serious injury.
Dosage & Administration
Directions
- do not exceed recommended dose
- adults and children 12 years and over: take 1 tablet every 6 hours, not more
- children under 12 years of age: do not use
than 4 tablets in 24 hours
Other Safety Information
Other information
- store between 20° to 25°C (68° to 77°F)
- see end flap for expiration date and lot number
Inactive Ingredient
Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)
Carton 16
Coricidin®
HBP
Decongestant-Free Cold
Symptom Relief for
People with High Blood Pressure
Cold and Cough
Dextromethorphan HBr-
Cough Suppresant
Chlorpheniramine Maleate-
Antihistamine
Relieves:
- Cough
- Runny nose
- Sneezing
16 TABLETS
* Please review the disclaimer below.