FDA Label for Walgreens Cold Cough And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Walgreens Cold Cough And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Purpose
Pain reliever/fever reducer
Cough Suppressant
Indications & Usage
Uses
- temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains
- headache
- cough
- sore throat
- temporarily reduces fever
Warnings
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.
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & 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
Other Safety Information
Other information
• each 30 mL contains: sodium 38 mg
• store between 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients
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
Otc - Questions
Questions or comments?1-866-467-2748
Package Label.Principal Display Panel
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
* Please review the disclaimer below.
