Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Cold And Flu Plus Congestion Solution
FDA Label NDC 79903-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Cold And Flu Plus Congestion (NDC 79903-190). 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 30 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
Expectorant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- promotes nasal and/or sinus drainage
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
- liver disease
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
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
- 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.
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
- mL = milliliter
- only use the dose cup provided
- do not exceed 4 doses per 24 hours
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years: do not use
Other Information
- each 30 mL contains: sodium 11 mg
- 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, D&C yellow #10, FD&C blue #1, flavors, glycerin, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose
Questions Or Comments?
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equate™
79903-190-12
Compare to
Vicks® DayQuil®
VapoCOOL® Severe
Cold & Flu + Congestion
active ingredients*
DAYTIME
SEVERE
VAPOR CHILLING
Cold & Flu
+ Congestion
• Acetaminophen -
Pain Reliever/Fever Reducer
• Dextromethorphan HBr -
Cough Suppressant
• Guaifenesin - Exectorant
•Phenylephrine HCl -
Nasal Deongestant
Relieves:
•Headache, fever, sore throat, minor aches & pains
•Chest congestion, cough
•Nasal congestion, sinus pressure
•Thins & loosens mucus
For Ages 12+
12 FL OZ (355 mL)
F-059
ORG
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by The Procter & Gamble Company,
owner of the registered trademark Vicks® DayQuil® VapoCOOL® SEVERE COLD &
FLU + CONGESTION
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Satisfaction guaranteed - Or we'll replace it or
give you your money back. For questions or
comments or to report an undesired reaction
or side effect, please call 1-888-287-1915.
Equate 44-059 (Equate 44 059 1) 
* Please review the disclaimer below.
