Active Ingredients (In Each Tablet)
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Cough And Cold Hbp Tablet, Film Coated
FDA Label NDC 36800-689
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Cough And Cold Hbp (NDC 36800-689). 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 or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, 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
persistent cough lasts for more than one week, tends to recur, or is accompanied by 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 (1-800-222-1222) right away.
Directions
- do not exceed recommended dose
- 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?
1-888-423-0139
Principal Display Panel
TopCare®
health™
NDC 36800-689-21
♥︎FOR PEOPLE WITH
HIGH BLOOD PRESSURE
COMPARE TO CORICIDIN® HBP COUGH & COLD ACTIVE INGREDIENTS*
Cough &
Cold HBP
CHLORPHENIRAMINE MALEATE
DEXTROMETHORPHAN HBr
ANTIHISTAMINE • COUGH SUPPRESSANT
Relieves:
• Cough
• Runny Nose
• Sneezing
•OUR PHARMACISTS RECOMMEND•
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 ORG111668921
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0118
QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com
QUALITY GUARANTEED
Topcare 44-689 (Topcare 44 689 1)
* Please review the disclaimer below.
