Active Ingredients (In Each Tablet)
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Cough And Cold Hbp Tablet, Film Coated
FDA Label NDC 50804-689
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn Inc. for the product Cough And Cold Hbp (NDC 50804-689). 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 active ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Cough suppressant
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
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.
Ask A Doctor Before Use If You Have
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with excessive phlegm (mucus)
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
cough persists 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours
- children under 12 years: do not use
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
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
Questions Or Comments?
1-800-426-9391
Principal Display Panel
GOODSENSE®
NDC 50804-689-21
Decongestant-free
Cough &
Cold HBP
Chlorpheniramine maleate
Dextromethorphan HBr
Antihistamine
Cough Suppressant
Relief of:
• Cough
• Runny Nose
• Sneezing
For People with High Blood Pressure
*Compare to the active ingredients of
Coricidin® HBP COUGH & COLD
16 Tablets
actual size
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered trademark
Coricidin® HBP COUGH & COLD.
50844 ORG022468921
Distributed by:
Perrigo Direct, Inc., Peachtree City, GA 30269
www.PerrigoDirect.com (1-800-426-9391)
GoodSense® is a registered trademark of L. Perrigo Company.
PARENTS:
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Goodsense 44-689 (Goodsense 44 689 1)
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