FDA Label for Coricidin Hbp Nighttime Multi-symptom Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOTE USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Coricidin Hbp Nighttime Multi-symptom Cold 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.
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan hydrobromide 15 mg | Cough suppresant |
Doxylamine succinate 6.25 mg | Antihistamine |
Purpose
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan hydrobromide 15 mg | Cough suppresant |
Doxylamine succinate 6.25 mg | Antihistamine |
Uses
temporarily relieves common cold/flu symptoms:
- headache
- sore throat
- runny nose
- minor aches and pains
- cough due to minor throat and bronchial irritation
- sneezing
- fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 120 mL (4 doses) in 24 hours, which is the maximum daily amount
- 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.
Do Note Use
- with any other products containing acetaminophen (prescription or nonprescription). If you are no 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.
Ask A Doctor Before Use If You Have
- liver disease
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- glaucoma
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- redness or swelling is present
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
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. (1-800-222-1222) Quick 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: take 30 mL in the dosing cup provided every 6 hours while symptoms last
- do not exceed 120 mL (4 doses) in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- each 15 mL contains: sodium 18 mg
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
alcohol 10%, anhydrous citric acid, FD&C blue no.1, FD&C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions Or Comments
Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)
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