Product Name
Coricidin HBP Max Strength Cold, Cough, and Flu
Coricidin HBP Max Strength Night Cold and Flu
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Coricidin Hbp Maximum Strength Nighttime Cold And Flu (NDC 11523-0077). 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 product name, 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.
Coricidin HBP Max Strength Cold, Cough, and Flu
Coricidin HBP Max Strength Night Cold and Flu
| Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20 mg | Cough suppressant |
| Active ingredients (in each 30mL) | Purposes |
| Acetaminophen 650mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20mg | Cough suppressant |
| Doxylamine succinate 12.5mg | Antihistamine |
Uses
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:
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.
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:
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.
Do not use to sedate children
Do not use
Do not use
Ask a doctor before use if you have
Ask a doctor befpre ise if you have
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
When using this product
If pregnant or breast-feeding, ask a health professional before use.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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.
Directions
Directions
Other information
• each 30 mL contains: sodium 38 mg
• store between 20° to 25°C (68° to 77°F)
Other information
• each 30 mL contains:
sodium 38 mg
• store between 20° to 25°C (68° to 77°F)
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
Inactive ingredients anhydrous sitric acid, FD&C blue #1, FD&C red#40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)
Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)
Stop use and ask a doctor if
* Please review the disclaimer below.