Coricidin Hbp Maximum Strength Cold , Cough & Flu Day/cold & Flu Night Bundle Uis 1615257/1614785

Coricidin Hbp Maximum Strength Cold , Cough & Flu Day/cold & Flu Night Bundle Uis 1615257/1614785
SPL v2
SPL
SPL Set ID 351d3c5c-05c8-921a-e063-6394a90abef9
Route
ORAL
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Acetaminophen (650 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Maltitol Polyethylene Glycol, Unspecified Propylene Glycol Saccharin Sodium Sodium Citrate Glycerin Fd&c Blue No. 1 Fd&c Red No. 40 Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12
Description

Coricidin HBP Max Strength Cold, Cough, and Flu

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than recommended dose
  • adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.
  • children under 12 years of age: do not use
Description

Coricidin HBP Max Strength Cold, Cough, and Flu

Section 50565-1

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.

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

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 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that is accompanied with excessive phlegm (mucus)
  • a sodium-restricted diet
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
  • in children under 12 years of age
Section 51727-6

Inactive ingredient s anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Section 51945-4

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 30 mL) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Section 60561-8

Other information

• each 30 mL contains: sodium 38 mg

• store between 20º to 25ºC (68º to 77ºF)

Product Name

Coricidin HBP Max Strength Cold, Cough, and Flu

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than recommended dose
  • adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor.
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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)

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that is accompanied with excessive phlegm (mucus)
  • a sodium-restricted diet
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
  • in children under 12 years of age
Section 51727-6 (51727-6)

Inactive ingredient s anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Section 51945-4 (51945-4)

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 30 mL) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Section 60561-8 (60561-8)

Other information

• each 30 mL contains: sodium 38 mg

• store between 20º to 25ºC (68º to 77ºF)

Product Name

Coricidin HBP Max Strength Cold, Cough, and Flu

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:27.316996 · Updated: 2026-03-14T23:10:55.855807