coricidin hbp

coricidin hbp
SPL v6
SPL
SPL Set ID e33f2319-2181-46db-a094-3e874b324c0a
Route
oral
Published
Effective Date 2015-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (200 mg) acetaminophen (500 mg) chlorpheniramine (2 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c red no. 40 gelatin polyethylene glycol 400 povidone propylene glycol sorbitol carnauba wax aluminum oxide hypromelloses lactose magnesium stearate cellulose, microcrystalline stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: C;NIGHT Shape: oval Color: red Size: 20 mm Size: 18 mm Score: 1
Marketing Status
otc monograph drug active Since 2009-08-28

Description

Coricidin HBP Day Drug Facts


Medication Information

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Directions
  • do not exceed recommended dose
  • do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product
  • adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours
  • children under 12 years of age: ask a doctor
Other Information
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
  • protect from excessive moisture
Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, povidone, propylene glycol, sorbitol

Description

Coricidin HBP Day Drug Facts

Section 42229-5

Coricidin HBP Day

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

Section 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

Section 50570-1

Do not use 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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each softgel) Purpose
Dextromethorphan hydrobromide 10 mg Cough Suppressant
Guaifenesin 200 mg Expectorant
Do Not Use
  • with any other drug containing acetaminophen (prescription or non prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.
Liver Warning

This product contains acetaminophen.

Sever liver damage may occur if you take

  • more than 4 tablets in 12 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

Questions Or Comments?

Call 1-800-317-2165 (MoN-Fri 9AM-5PM EST)

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
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 a rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • cough that occurs with excessive phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel Kit Carton

DUAL FORMULA PACK



Coricidin ®



HBP

Decongestant-free COLD RELIEF for people



with HIGH BLOOD PRESSURE

DAY

MULTI-SYMPTOM COLD

Guaifenesin - Expectorant



Dextromethorphan HBr - Cough Suppressant

Day Relieves:

  • Chest Congestion
  • Cough

16 DAY SOFTGELS

NIGHT

Chlorpheniramine Maleate - Antihistamine,



Dextromethorphan HBr - Cough Suppressant,



Acetaminophen - Pain Reliever/Fever Reducer

See New Warnings Information

Night Relieves:

  • Runny Nose & Sneezing
  • Cough • Body Aches
  • Fever

8 NIGHT TABLETS

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Directions
  • do not exceed recommended dose
  • do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product
  • adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours
  • children under 12 years of age: ask a doctor
Other Information
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
  • protect from excessive moisture
Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, povidone, propylene glycol, sorbitol

Section 42229-5 (42229-5)

Coricidin HBP Day

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

Section 50570-1 (50570-1)

Do not use 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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Dextromethorphan hydrobromide 10 mg Cough Suppressant
Guaifenesin 200 mg Expectorant
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.
Liver Warning

This product contains acetaminophen.

Sever liver damage may occur if you take

  • more than 4 tablets in 12 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

Questions Or Comments? (Questions or comments?)

Call 1-800-317-2165 (MoN-Fri 9AM-5PM EST)

When Using This Product (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
Stop Use and Ask A Doctor If (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 a rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with excessive phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

DUAL FORMULA PACK



Coricidin ®



HBP

Decongestant-free COLD RELIEF for people



with HIGH BLOOD PRESSURE

DAY

MULTI-SYMPTOM COLD

Guaifenesin - Expectorant



Dextromethorphan HBr - Cough Suppressant

Day Relieves:

  • Chest Congestion
  • Cough

16 DAY SOFTGELS

NIGHT

Chlorpheniramine Maleate - Antihistamine,



Dextromethorphan HBr - Cough Suppressant,



Acetaminophen - Pain Reliever/Fever Reducer

See New Warnings Information

Night Relieves:

  • Runny Nose & Sneezing
  • Cough • Body Aches
  • Fever

8 NIGHT TABLETS

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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