walgreen cold , cough & flu

walgreen cold , cough & flu
SPL v2
SPL
SPL Set ID 1e903034-942e-4c6e-9f96-eb097c266580
Route
oral
Published
Effective Date 2025-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (650 mg) dextromethorphan (20 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin poloxamer 105 propylene glycol water sodium benzoate potassium citrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2025-04-01

Purpose

Pain reliever/fever reducer Cough Suppressant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg


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
Purpose

Pain reliever/fever reducer

Cough Suppressant

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

Acetaminophen 650 mg Dextromethorphan HBr 20 mg

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 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 aretaking 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, Edetate Disodium, FD&C blue #1, FD&C red # 40, flavor, glycerin, Poloxamer, propylene glycol, purified water, Sodium benzoate, potassium Citrate, sorbitol liquid, xanthan gum

Section 51945-4

Walgreens

Compare to the active ingredients in Coricidin® HBP Maximum Strength††

NDC# 0363-8100-12

Cold, Cough & Flu Relief

ACETAMINOPHEN 650 mg /PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg /COUGH SUPPRESSANT

Maximum Strength

  • For relief of sore throat, fever, headache, cough, body aches & pains
  • Cold relief for people with high blood pressure*
  • sugar free
  • Alcohol Free

Natural Cherry flavor

*Decongestant free

Maximum Strength per 4-hour dose

12 FL OZ (355 mL)

†Our pharmacist recommend the Walgreens brand. We invite you to compare to national brands.

††This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP.

DISTRIBUTED BT: WALGREEN CO.,

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Walgreens.com

©2025 Walgreen Co.

MADE IN THE U.S.A. WITH DOMESTIC AND IMPORTED INGREDIENTS

Section 53413-1

Questions or comments?1-866-467-2748

Section 53414-9

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

Section 60561-8

Other information

• each 30 mL contains: sodium 38 mg

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

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg


Structured Label Content

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.

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
Purpose

Pain reliever/fever reducer

Cough Suppressant

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
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 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 aretaking 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, Edetate Disodium, FD&C blue #1, FD&C red # 40, flavor, glycerin, Poloxamer, propylene glycol, purified water, Sodium benzoate, potassium Citrate, sorbitol liquid, xanthan gum

Section 51945-4 (51945-4)

Walgreens

Compare to the active ingredients in Coricidin® HBP Maximum Strength††

NDC# 0363-8100-12

Cold, Cough & Flu Relief

ACETAMINOPHEN 650 mg /PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg /COUGH SUPPRESSANT

Maximum Strength

  • For relief of sore throat, fever, headache, cough, body aches & pains
  • Cold relief for people with high blood pressure*
  • sugar free
  • Alcohol Free

Natural Cherry flavor

*Decongestant free

Maximum Strength per 4-hour dose

12 FL OZ (355 mL)

†Our pharmacist recommend the Walgreens brand. We invite you to compare to national brands.

††This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Coricidin® HBP.

DISTRIBUTED BT: WALGREEN CO.,

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Walgreens.com

©2025 Walgreen Co.

MADE IN THE U.S.A. WITH DOMESTIC AND IMPORTED INGREDIENTS

Section 53413-1 (53413-1)

Questions or comments?1-866-467-2748

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information

• each 30 mL contains: sodium 38 mg

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

Active Ingredients (in Each 30 Ml) (Active Ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)