Coricidin Hbp Kit
FDA Label NDC 11523-4765

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Coricidin Hbp (NDC 11523-4765). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredients (in each softgel)Purpose
Dextromethorphan hydrobromide 10 mgCough Suppressant
Guaifenesin 200 mgExpectorant
Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 15 mgCough Suppressant

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
    • temporarily relieves
      • minor aches and pains
      • headache
      • cough
      • runny nose
      • sneezing
      • temporarily reduces fever

Otc - Do Not Use

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.

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
    • liver disease
    • glaucoma
    • 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

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

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. Abuse of this product can lead to serious injury.

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

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
    • do not use more than directed (see overdose warning)
    • do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product
    • adults and children 12 years and over: 2 tablets at bedtime and every 6 hours if needed, while symptoms persist, not more than 4 tablets in a 12 hour period
    • 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
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

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

carnauba wax, FD&C red No. 40 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

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

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.

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 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.

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.

* Please review the disclaimer below.