Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Triprolidine HCl 2.5 mg
Cold And Flu Solution
FDA Label NDC 0363-8078
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Cold And Flu (NDC 0363-8078). 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 active ingredients (in each 20 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- sore throat
- minor aches and pains
- cough
- sinus congestion and pressure
- sneezing
- itching of the nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- headache
- temporarily reduces fever
- controls cough to help you get to sleep
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin 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.
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
Ask A Doctor Before Use If You Have
- diabetes
- cough that occurs with too much phlegm (mucus)
- heart disease
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- thyroid disease
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- do not take more than 4 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 0363-8078-45
Walgreens
• WALGREENS •
PHARMACIST RECOMMENDED†
Compare to the active ingredients in
Maximum Strength Mucinex®
NIGHTSHIFT® Severe Cold & Flu††
NIGHTTIME
Severe
Cold & Flu
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
TRIPROLIDINE HCl / ANTIHISTAMINE
Maximum Strength
• Relieves headache, body pain,
sore throat, fever, itchy throat,
cough, nasal congestion,
runny nose & sneezing
• 12 years & older
6 FL OZ (177 mL)
†Our pharmacists
recommend the
Walgreens brand.
We invite you to
compare to national brands.
††This product is not manufactured or
distributed by RB Health (US) LLC, owner of the
registered trademark Maximum Strength
Mucinex® NIGHTSHIFT® Severe Cold & Flu.
DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.
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