Active Ingredients (In Each Tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Cold And Flu Hbp Tablet, Film Coated
FDA Label NDC 69842-692
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cold And Flu Hbp (NDC 69842-692). 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, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Antihistamine
Uses
- temporarily relieves:
- headache
- sneezing
- runny nose
- minor aches and pains
- sore throat
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen: Severe liver damage may occur if
- adults take more than 12 tablets in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- blisters
- rash
- skin reddening
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If The User Has
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The User Is
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- drowsiness may occur
- avoid alcoholic beverages
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not take more than directed
| adults and children 12 years and over | 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours |
| children 6 to under 12 years | 1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours |
| children under 6 years | ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn starch, crospovidone, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
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Health™
Compare to the active ingredients
in Coricidin® HBP Cold & Flu*
Decongestant Free
NDC 69842-692-09
Cold &
Flu HBP
ACETAMINOPHEN - Pain reliever/Fever reducer
CHLORPHENIRAMINE MALEATE - Antihistamine
For People with
High Blood Pressure
Relieves:
•Runny nose
•Sneezing
•Body aches & pains
•Fever
20 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 Cold & Flu. 50844 ORG051769209
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849
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Money Back Guarantee
Cvs 44-692 (Cvs 44 692 1)
* Please review the disclaimer below.
