FDA Label for Coricidin Hbp Maximum Strength Cold And Flu Day And Night
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS
- USES
- WARNINGS
- DO NOT USE
- ASKA A DOCTOR
- ASK A DOCTOR OR PHARMACIST
- STOP USE
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENS
- QUESTIONS OR COMMENTS?
- OTC - ACTIVE INGREDIENT
- LIVER WARNING
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- 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 And Flu Day And Night 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 Cold & Flu Day Liquid Gels
Coricidin® HBP Maximum Strength Cold & Flu Liquid Gels
Active Ingredients
Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg…………….………..Pain reliever/fever reducer
Guaifenesin 200 mg…………………………………………...Expectorant
Uses
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache
· sore throat
· helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive
· temporarily reduces fever
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains · headache · cough
- sore throat · runny nose · sneezing
- 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.
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 have ever had an allergic reaction to this product or any of its
ingredients
● in children under 12 years of age
Aska A Doctor
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 occurs with excess phelgm
Ask A Doctor Or Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions
· do not take more than the recommended dose
· do not take the Day and Night products at the same time; wait 4
hours after taking the last Night dose before taking the Day product.
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 6 capsules in 12 hours or as
directed by a doctor.
· children under 12 years of age: do not use
Other Information
Other information
· store at 15°-25°C (59°-77°F)
Inactive Ingrediens
Inactive ingredientsFD&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?
Questions or comments? 1-800-317-2165 (Mon-Fri 9AM -5PM EST)
Otc - Active Ingredient
Active ingredients (in each capsule)Purposes
Acetaminophen 325 mg…………….………...Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Doxylamine succinate 6.25 mg……………………………...Antihistamine
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: 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 to sedate children
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/Pharmacist
Ask a doctor before use if you have
● liver disease ● glaucoma
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● cough that occurs with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
Otc - When Using
When using this product
● may cause marked drowsiness
● avoid alcoholic beverages
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in children
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. 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 the recommended dose
· do not take the Day and Night products at the same time; wait 4
hours after taking the last Day dose before taking the Night product.
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 4 capsules in 12 hours or as
directed by a doctor.
· children under 12 years of age: do not use
Other Safety Information
Other information
· store at 15°-25°C (59°-77°F)
Inactive Ingredient
Inactive ingredients D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, lecithin, medium-chain triglycerides, silica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, soybean oil, titanium dioxide
Otc - Questions
Questions or comments?1-800-317-2165 (Mon-Fri 9AM -5PM EST)
Package Label.Principal Display Panel
Coricidin® HBP
COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ
MAXIMUM STRENGTH
COLD & FLU DAY
ACETAMINOPHEN - Pain Reliever/Fever Reducer
GUAIFENESIN - Expectorant
Relieves
- Body Aches & Pains
- Headache
- Chest Congestion
- Sore Throat
- Fever
- Body Aches & Pains
- Headache
- Runny Nose & Sneezing
- Cough
- Sore Throat
- Fever
Ɨ Decongestant Free
16 LIQUID GELS
(Liquid Filled Capsules)
COLD & FLU NIGHT
DOXYLAMINE SUCCINATE - Antihistamine
ACETAMINOPHEN - Pain Reliever/Fever Reducer
DEXTROMETHORPHAN HBr- Cough Suppressant
RELIEVES
Ɨ Decongestant Free
8 LIQUID GELS
(Liquid Filled Capsules)
* Please review the disclaimer below.