Coricidin Hbp Max Strength Multi-symptom Flu (tablet) New Product Name Perrigo Old Name Coricidin Hbp Max Strength (tablet)

Coricidin Hbp Max Strength Multi-symptom Flu (tablet) New Product Name Perrigo Old Name Coricidin Hbp Max Strength (tablet)
SPL v5
SPL
SPL Set ID ae7cf41e-b618-d6bb-e053-2a95a90a6692
Route
ORAL
Published
Effective Date 2020-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Talc Starch, Corn Microcrystalline Cellulose Titanium Dioxide Polyethylene Glycol, Unspecified Fd&c Red No. 40 Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: c;flu Shape: oval Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Coricidin HBP Maximum Strength Multi-Symptom Flu


Medication Information

Dosage and 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

Description

Coricidin HBP Maximum Strength Multi-Symptom Flu

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
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

Section 42229-5

Coricidin HBP

Maximum Strength Multi-Symptom Flu

Section 50565-1

Keep out of reach of children. Abuse of this product can lead to serious injury.

Section 50566-9

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.
Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

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
Section 50570-1

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
Section 51727-6

Inactive ingredients FD&C red #40 aluminum lake, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Section 53413-1

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)

Section 53414-9

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

Section 60561-8

Other information

store at room temperature. Avoid excessive heat.

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.

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
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.

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

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.


Structured Label Content

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
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

Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)

Coricidin HBP

Maximum Strength Multi-Symptom Flu

Section 50565-1 (50565-1)

Keep out of reach of children. Abuse of this product can lead to serious injury.

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients FD&C red #40 aluminum lake, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM - 5PM EST)

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information

store at room temperature. Avoid excessive heat.

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.

Liver Warning (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
Overdose Warning (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.

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

Sore Throat Warning (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.


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