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Cold and Flu Relief DayTime by WinCo Foods, LLC

Medically reviewed on October 11, 2016

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-308

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves common cold and 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 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 reactions. Symptoms may include

  • Skin reddening
  • blisters
  • rash

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.

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

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
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness or sleeplessness occur
  • 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.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat

Inactive ingredients

butylated hydroxyanisole*, butylated hydroxytoluene* carminic acid*, edible white ink, D&C yellow#10*, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, and sorbitol

*contains one or more of these ingredients

Questions or comments?

Or to report an adverse event Call 800-824-1706 Monday-Friday 9am- 4pm MST

Principal Display Panel

MULTI-SYMPTOM

Cold & Flu Relief

DayTime

†Compare to the active ingredients in VICKS® DAYQUIL® Cold & Flu LiquiCaps®

Non-Drowsy

Relieves: Aches, Fever, Sore Throat, Cough & Nasal Congestion

Alcohol-Free

& Antihistamine-Free

ACETAMINOPHEN /  PAIN RELIEVER - FEVER REDUCER 

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

Softgels**

**Liquid-Filled Capsules

†This product is not manufactured or distributed by THE PROCTER & GAMBLE COMPANY, VICKS®, DAYQUIL®, and LiquiCaps® are registered trademarks of THE PROCTER & GAMBLE COMPANY.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

www.wincofoods.com

Product Label

WinCo FOODS Multi-Symptom Cold & Flu Relief

COLD AND FLU RELIEF  DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hci capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-308
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
CARMINIC ACID 
D&C YELLOW NO. 10 
SODIUM METABISULFITE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeP19;95A;512;P119
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-308-242 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/30/2016
Labeler - WinCo Foods, LLC (056098817)

 
WinCo Foods, LLC

← See all Cold and Flu Relief DayTime brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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