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Cold and Flu Relief Multi symptom

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-287

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 15 mL)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

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

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
  • 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
adults and children 12 years and over30 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
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Other information
  • each 15 mL contains: sodium 12 mg
  • store between 20-25ºC (68-77ºF). 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

COLD AND FLU RELIEF  MULTI SYMPTOM
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-287
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 6 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
TRISODIUM CITRATE DIHYDRATE 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:67091-287-54355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/28/2017
Labeler - WinCo Foods, LLC (056098817)

Revised: 03/2017
 
WinCo Foods, LLC

← See all Cold and Flu Relief Multi symptom 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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