FDA Label for Coricidin Hbp Maximum Strength Multi Symptom Flu
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- CARTON
Coricidin Hbp Maximum Strength Multi Symptom 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
Coricidin HBP
Maximum Strength Multi-Symptom Flu
Drug Facts
Active Ingredient
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg………………….………….Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……….......................................Antihistamine
Dextromethorphan hydrobromide 10 mg…………………..Cough suppressant
Uses
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- runny nose
- sneezing
- sore throat
- temporarily reduces fever
Liver Warning
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
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
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
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with excessive phlegm (mucus)
- a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - When Using
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - Stop Use
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. Abuse of this product can lead to serious injury.
Overdose Warning
Overdose warning: Taking more than the recommended dose may cause liver damage. 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 children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
do not use more than directed (see overdose warning)
adults and children 12 years and over: take 2 tablets every 4 hours, while symptoms persist. Do not take more than 10 tablets in 24 hours or as directed by a doctor.
children under 12 years of age: ask a doctor
Other Safety Information
Other information
store at room temperature. Avoid excessive heat.
Inactive Ingredient
Inactive ingredients FD&C red #40 aluminum lake, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)
Carton
Coricidin®
HBP COLD RELIEF FOR PEOPLE WITH
HIGH BLOOD PRESSUREƗ
MAXIMUM STRENGTH
MULTI-SYMPTOM
FLU
Relieves
- Body Aches & Pains
- Headache
- Fever
- Cough
- Runny Nose & Sneezing
- Sore Throat
ƗDecongestant Free
24 tablets
Acetaminophen - Pain Reliever/Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough Supressant
LEARN MORE
American Heart Association
Information Enclosed
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