Effervescent Cold Relief Tablets

Manufacturer
WinCo Foods, LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:14

Label at a glance#

ProductWinCo Foods Effervescent Cold Relief
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Label structure17 sections

Indications and uses

temporarily relieves these symptoms of the common cold ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure

Dosage and administration

■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4-6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine Bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Uses

temporarily relieves these symptoms of the common cold:

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of the common cold

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Warnings

WARNINGS SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

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

OTC - DO NOT USE SECTION

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin

■ 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

OTC - ASK DOCTOR SECTION

■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic. ■ you are taking sedatives or tranquilizers. You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

When using this product

OTC - WHEN USING SECTION

do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.

■ do not use more than directed ■ you may get drowsy ■ avoid alcoholic drinks

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ you experience any of the following signs of stomach bleeding

■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away. ■ pain or nasal congestion gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs ■ nervousness, dizziness or sleeplessness occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose,

OVERDOSAGE SECTION

get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not use more than directed (see overdose warning)

■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4-6 hours

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

each tablet contains:
sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

■ store at room temperature (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium

benzoate, sodium bicarbonate

Questions?

OTC - QUESTIONS SECTION

Or to report an adverse event call

800-824-1706 Monday - Friday

9am - 4pm MST

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winco Cold 20ctWinco Cold 20ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSN4
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCD4
1536840ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-109-20WinCo Foods Effervescent Cold Relief2 in 1 POUCHTABLET, EFFERVESCENT24
67091-109-20WinCo Foods Effervescent Cold Relief10 in 1 CARTONTABLET, EFFERVESCENT104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-109WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC]4Current NDC, Legacy NDC, 2 package rows20241115_d443a030-d3d6-40e0-8fe0-329de6bc494f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
PHENYLEPHRINE BITARTRATEACTIVE INGREDIENT27O3Q5ML571
ASPIRINACTIVE MOIETYR16CO5Y76E1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA01
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
POVIDONE K30INACTIVE INGREDIENTU725QWY32X1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-10967091-109-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, DELAYED RELEASE / ORAL639 mgExact identifier — unii+route
52 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / ORAL869 mgExact identifier — unii+route
52 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0TABLET, COATED / ORAL1 mgExact identifier — unii+route
16 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, ORALLY DISINTEGRATING / ORAL71 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XPOWDER, FOR SOLUTION / ORAL2832 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
52 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FOR SUSPENSION / ORAL7621 mgExact identifier — unii+route
52 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii+route
34 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii+route
34 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION / ORAL148 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XPOWDER / ORAL378 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii+route
52 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SUSPENSION, EXTENDED RELEASE / ORAL0.77 mgExact identifier — unii+route
16 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE / ORAL202 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FOR SUSPENSION / ORAL7621 mgExact identifier — unii+route
52 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SUSPENSION / ORAL48 mgExact identifier — unii+route
16 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, EXTENDED RELEASE / ORAL368 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii+route
58 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SUSPENSION / ORAL420 mgExact identifier — unii+route
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii+route
52 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1CAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATROCHE / ORAL14594 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, DELAYED RELEASE PELLETS / ORAL178 mgExact identifier — unii+route
58 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii+route
34 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1GRANULE, EFFERVESCENT / ORAL30 mgExact identifier — unii+route
34 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE, EFFERVESCENT / ORAL40 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSOLUTION / ORAL300 mgExact identifier — unii+route
58 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii+route
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, FOR SUSPENSION / ORAL462 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, DELAYED RELEASE / ORAL227 mgExact identifier — unii+route
58 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
58 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION, EXTENDED RELEASE / ORAL474 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route
52 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii+route
52 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, FILM COATED / ORAL245 mgExact identifier — unii+route
58 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii+route
52 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii+route
34 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
16 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii+route
52 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1SOLUTION / ORAL40 mgExact identifier — unii+route
34 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, ORALLY DISINTEGRATING / ORAL71 mgExact identifier — unii+route
58 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0TABLET / ORAL50 mgExact identifier — unii+route
16 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii+route
52 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo Foods Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEWinCo Foods, LLCd443a030-d3d6-40e0-8fe0-329de6bc494f2024-11-13WarningsExact identifier
ndc (package): 67091-109-20
ndc (product): 67091-109
ndc11 (package): 67091010920
spl id: 26d1b568-ad98-80d7-e063-6394a90a2cbf
spl set id: d443a030-d3d6-40e0-8fe0-329de6bc494f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.