CuRELIEF

Manufacturer
Wittman Pharma, Inc.
Effective date
2024-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:14

Label at a glance#

ProductCuRELIEF
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Take every 4-6 hours, or as directed by doctor. * Do NOT exceed the recommended dose

AgeDose
Adults and Children 12 years of age and overtake 10 to 20 mL (2 to 4 tsp), not to exceed 300 mg in 24 hours
Children 6 to under 12 years of agetake 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
Children under 6 years of ageConsult a doctor

WARNINGS SECTION

Warnings:

Do not use: ■ with any other product containing

diphenhydramine, even one used on skin ■ to make a

child sleepy

Ask a doctor before use if you have: ■ a breathing

problem such as emphysema or chronic bronchitis

■ glaucoma ■ trouble urinating due to the enlarged

prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product: ■ excitability might occur,

especially in children ■ marked drowsiness may occur

■ avoid alcoholic drinks ■ alcohol, sedatives, and

tranquilizers may increase drowsiness effect ■ be careful

when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health

professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center (1-800-222-1222) right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric Acid,

Flavor, Methylparaben, Monoammonium

Glycyrrhizinate, Potassium Citrate, Propylene Glycol,

Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves these symptoms due

to hay fever or other upper respiratory allergies: ■

runny nose ■ sneezing ■ itchy, watery eyes ■

itching of the nose or throat ■ Temporarily relieves

these symptoms due to the common cold: ■ runny

nose ■ sneezing

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 (1-800-222-1222) right away.

OTC - PURPOSE SECTION

Purpose: Antihistamine

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL tsp)

Diphenhydramine HCL, 12.5 mg

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CuRELIEF LabelCuRELIEF Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83335-103-042025-07-29C16284748780-13b156c62-2783-fb37-e063-e6dba90a4e07CuRELIEF
83335-103-162025-07-29C16284748780-13b156c62-2783-fb37-e063-e6dba90a4e07CuRELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83335-103-04CuRELIEF118 mL in 1 BOTTLE, PLASTICSOLUTION1183
83335-103-16CuRELIEF473 mL in 1 BOTTLE, PLASTICSOLUTION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83335-103CURELIEF (DIPHENHYDRAMINE HCL) SOLUTION [WITTMAN PHARMA, INC.]32 package rows20240420_12ed851d-94d6-d030-e063-6394a90a6ebd.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83335-10383335-103-16, 83335-103-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
16633c42-25c7-b6eb-e063-6394a90a872a12ed851d-94d6-d030-e063-6394a90a6ebd2024-04-18WarningsExact identifier
spl id: 16633c42-25c7-b6eb-e063-6394a90a872a
spl set id: 12ed851d-94d6-d030-e063-6394a90a6ebd

Reported adverse events (FAERS/openFDA)#

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