FDA.reportPublic FDA data

Complete Allergy Relief

Manufacturer
WinCo Foods LLC | TIME CAP LABORATORIES, INC.
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:31

Label at a glance#

ProductComplete Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

INDICATIONS & USAGE SECTION

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• itchy, watery eyes
• sneezing
• itchy nose or throat
temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• glaucoma
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
adults and children 12 years of age and over: 1 to 2 caplets
children 6 to under 12 years of age: 1 caplet
children under 6 years of age: do not use this product in children under 6 years of age

OTHER SAFETY INFORMATION

Other information
• each caplet contains: calcium 25 mg
• protect from light
• store at 25°C (77° F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

OTC - QUESTIONS SECTION

Questions? Call 1-800-824-1706

Monday - Friday 9 am-4pm MST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160R-Winco-Allergy-Relief-bottle-label-100s160R-Winco-Allergy-Relief-bottle-label-100s160R-Winco-Allergy-Relief-carton-label-100s160R-Winco-Allergy-Relief-carton-label-100s160R-Winco-Allergy-Relief-carton-label-24s160R-Winco-Allergy-Relief-carton-label-24s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-381-102025-01-30C16284748780-12cef2736-8b81-d83d-e063-dadaa90ab31f160R Winco Foods 67091 381 Diphenhydramine HCl 25 mg 24ct and 100ct
67091-381-242025-01-30C16284748780-12cef2736-8b81-d83d-e063-dadaa90ab31f160R Winco Foods 67091 381 Diphenhydramine HCl 25 mg 24ct and 100ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-381-10Complete Allergy Relief1 in 1 CARTONTABLET12
67091-381-10Complete Allergy Relief100 in 1 BOTTLETABLET1002
67091-381-24Complete Allergy Relief24 in 1 BLISTER PACKTABLET242
67091-381-24Complete Allergy Relief1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-381COMPLETE ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25MG) TABLET [WINCO FOODS LLC]2Legacy NDC, 4 package rows20220125_c34e71c2-e974-a4b3-e053-2a95a90af89a.zip

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
67091-38167091-381-24, 67091-381-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
HYPROMELLOSES3NXW29V3WOIACT

Source Document#

Source XML

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
d4e4b743-40ff-3666-e053-2995a90a4131c34e71c2-e974-a4b3-e053-2a95a90af89a2022-01-06WarningsExact identifier
spl id: d4e4b743-40ff-3666-e053-2995a90a4131
spl set id: c34e71c2-e974-a4b3-e053-2a95a90af89a

Reported adverse events (FAERS/openFDA)#

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