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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Coricidin Hbp Maximum Strength Cold Flu And Chest Congestion (NDC 11523-0094). 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 other, otc - purpose, uses, warnings, do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients
(in each tablet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/ fever reducer |
| Guaifenesin 200 mg | Expectorant |
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
● 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
● in children under 12 years of age
Ask a doctor before use if you have ● liver disease ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● cough that is accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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.
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.
• do not take more than the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not
exceed 10 capsules in 24 hours or as directed by a doctor.
• children under 12 years of age: do not use
● store at 15°-25°C (59°-77°F)
FD&C yellow # 6, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, mica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol,purified water, shellac, sodium hydroxide, sorbitol sorbitan solution,titanium dioxide
Questions or comments? 1-800-317-2165 (Mon-Fri 9AM -5PM EST)
Coricidin
®
HIGH BLOOD PRESSURE
Acetaminophen - Pain Reliever/Fever Reducer
Guaifenesin - Expectorant
24 Liquid Gels
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