Coricidin Hbp Cough And Cold Ui 1614831

Coricidin Hbp Cough And Cold Ui 1614831
SPL v5
SPL
SPL Set ID b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d
Route
ORAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Anhydrous Lactose Polyethylene Glycol, Unspecified Stearic Acid D&c Red No. 27 Aluminum Lake Silicon Dioxide Titanium Dioxide Croscarmellose Sodium Polyvinyl Alcohol, Unspecified Magnesium Stearate Talc Microcrystalline Cellulose Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: CC Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-23

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves runny nose and sneezing due to the common cold
Dosage and Administration

Directions

  • do not exceed recommended dose
  • adults and children 12 years and over: take 1 tablet every 6 hours, not more

than 4 tablets in 24 hours

  • children under 12 years of age: do not use
Description

Drug Facts

Section 42229-5

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 persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Do not use to sedate children.

Section 51727-6

Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, 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 55106-9

Active ingredients (in each tablet) Purpose

Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant

Section 60561-8

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • see end flap for expiration date and lot number
Carton 16

Coricidin®

HBP

Decongestant-Free Cold

Symptom Relief for

People with High Blood Pressure

Cold and Cough

Dextromethorphan HBr-

Cough Suppresant

Chlorpheniramine Maleate-

Antihistamine

Relieves:

  • Cough
  • Runny nose
  • Sneezing

16 TABLETS


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves runny nose and sneezing due to the common cold
Dosage and Administration (34068-7)

Directions

  • do not exceed recommended dose
  • adults and children 12 years and over: take 1 tablet every 6 hours, not more

than 4 tablets in 24 hours

  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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 persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Do not use to sedate children.

Section 51727-6 (51727-6)

Inactive ingredients croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, 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 55106-9 (55106-9)

Active ingredients (in each tablet) Purpose

Chlorpheniramine maleate 4 mg………………………….....................Antihistamine

Dextromethorphan hydrobromide 30 mg……………………… .Cough suppressant

Section 60561-8 (60561-8)

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • see end flap for expiration date and lot number
Carton 16

Coricidin®

HBP

Decongestant-Free Cold

Symptom Relief for

People with High Blood Pressure

Cold and Cough

Dextromethorphan HBr-

Cough Suppresant

Chlorpheniramine Maleate-

Antihistamine

Relieves:

  • Cough
  • Runny nose
  • Sneezing

16 TABLETS


Advanced Ingredient Data


Raw Label Data

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