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Drug Facts
Coricidin Hbp Cough And Cold Tablet
FDA Label NDC 50090-5534
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Coricidin Hbp Cough And Cold (NDC 50090-5534). 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 - active ingredient, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
How Supplied
Product: 50090-5534
NDC: 50090-5534-0 8 TABLET in a BLISTER PACK / 2 in a CARTON
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