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Cold, Flu and Sore Throat Relief Maximum Strength, Multi Symptom

Medically reviewed on April 30, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WinCo Foods, LLC
NDC Code: 67091-293

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.

Winco 44-616

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sore throat
    • headache
    • minor aches and pains
    • cough
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

 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
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • 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
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 12 caplets in any 24-hour period
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º F)
  • use by expiration date on package

Inactive ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

Or to report a side effect call 800-824-1706
Monday - Friday 9am - 4pm MST

Principal Display Panel

WinCo™
FOODS

MAXIMUM STRENGTH

Cold, Flu &
Sore Throat Relief

Multi-Symptom

ACETAMINOPHEN/
PAIN RELIEVER - FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT

30 Caplets

50844    REV0117A61601

Relieves Headache, Fever, Sore Throat,
Nasal & Chest Congestion. Controls
Cough, Thins & Loosens mucus

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

*Compare to the active ingredients in Maximum Strength MUCINEX® FAST-MAX® Cold, Flu & Sore Throat

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY: WINCO FOODS, LLC
BOISE, ID 83704

*This product is not manufactured or distributed by RECKITT BENCKISER LLC, distributor of Maximum Strength MUCINEX® FAST-MAX® Cold, Flu & Sore Throat.

100% SATISFACTION GUARANTEE
Comments & Questions?
800-824-1706 www.wincofoods.com

Winco 44-616


COLD, FLU AND SORE THROAT RELIEF  MAXIMUM STRENGTH, MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-293
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;616
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-293-303 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/07/2013
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(67091-293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(67091-293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(67091-293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(67091-293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(67091-293)

 
WinCo Foods, LLC

← See all Cold, Flu and Sore Throat Relief Maximum Strength, Multi Symptom brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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