FDA Label for Coricidin Hbp Maximum Strength Cold, Cough And Flu
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 - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Coricidin Hbp Maximum Strength Cold, Cough And Flu 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 30 mL) | Purposes |
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan hydrobromide 20 mg | Cough suppressant |
Indications & Usage
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- sore throat
- temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin or general allergic 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.
Otc - Do Not Use
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 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
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that is accompanied with excessive phlegm (mucus)
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - When Using
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- do not take more than recommended dose
- adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.
- children under 12 years of age: do not use
Other Safety Information
Other information
• each 30 mL contains: sodium 38 mg
• store between 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Otc - Questions
Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)
Package Label.Principal Display Panel
New Formula!
Coricidin®
HBP
COLD RELIEF FOR PEOPLE WITH
HIGH BLOOD PRESSURE†
MAXIMUM STRENGTH
NIGHTTIME
COLD
& FLU
Relieves
Body Aches & Pains
Headache, Fever,
Cough, Sore Throat,
SUGAR FREE
Alcohol Free
Cherry
†Decongestant Free
Acetaminophen -
Pain Reliever/Fever Reducer
Dextromethorphan HBr-
Cough Suppressant
12 FL OZ (355 mL)
* Please review the disclaimer below.