ALLERGY AND PAIN RELIEF MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated 
WinCo Foods, LLC

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.

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Winco 44-455C-AMS

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg 

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • headache
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
    • sinus congestion and pressure
  • temporarily relieves these additional symptoms of hay fever:
    • itchy, watery eyes
    • itching of the nose or throat
  • helps clear nasal passages
  • helps decongest sinus openings and passages 

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
  • 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:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • high blood pressure
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • thyroid disease
  • diabetes
  • liver disease

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause drowsiness

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

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-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

Questions?

Call 800-824-1706 Monday - Friday 9am - 4pm MST 

Principal Display Panel

 *Compare to the active ingredients in TYLENOL® Allergy Multi-Symptom

WinCo®
FOODS

MULTI-SYMPTOM
Allergy &
Pain Relief 

ACETAMINOPHEN / PAIN RELIEVER
CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE
PHENYLEPHRINE HCl / NASAL DECONGESTANT

Relieves: Sinus Headache, Runny Nose & Sneezing,
Sinus Pressure, Itchy & Watery Eyes
and Nasal Congestion

24
Caplets

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

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by MCNEIL CONSUMER HEALTHCARE, distributor of TYLENOL® Allergy Multi-Symptom.

50844     REV0616B45508     WF1612

100% SATISFACTION GUARANTEE

Comments & Questions?
800-824-1706

Winco 44-455C-AMS

Winco 44-455C-AMS

ALLERGY AND PAIN RELIEF  MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSPOVIDONE (UNII: 2S7830E561)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;455
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-210-242 in 1 CARTON06/28/200501/06/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/28/200501/06/2022
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(67091-210)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(67091-210)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(67091-210)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(67091-210)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(67091-210)

Revised: 3/2021
Document Id: 76b5eaa9-04b8-42a4-b94a-436f37033de7
Set id: 08b95554-0063-46d4-b639-c2aa28791274
Version: 9
Effective Time: 20210325
 
WinCo Foods, LLC