Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Cold And Flu Relief Liquid
FDA Label NDC 67091-287
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Cold And Flu Relief (NDC 67091-287). 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 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, 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
Uses
- temporarily relieves common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
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 5 days(children) or 7 Days (adult)
- fever gets worse, or last 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to 6 years | ask a doctor |
| children under 4 years | do not use |
Other Information
- each 15 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
citric acid, FD&C yellow 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions?
Or to report an adverse event call 800-824-1706 Monday-Friday 9am-4pm MST
Principal Display Panel
*Compare to the active ingredients in Vicks® DayQuil®
Multi-Symptom
Cold & Flu Relief
Daytime
ACETAMINOPHEN /
PAIN RELIEVER- FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCI /NASAL DECONGESTANT
Non-Drowsy, For Ages 6 & Over
Alcohol and antihistamine free
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
*This product is not manufactured or distributed by THE PROCTER & GAMBLE COMPANY, VICK® and DAYQUIL® are registered trademarks of THE PROCTER & GAMBLE COMPANY.
Comments & Questions? 800-824-1706 www.wincofoods.com
Package Label
WinCo FOODS DayTime Multi-Symptom Cold & Flu Relief
* Please review the disclaimer below.
