Dr. Simi Allergy Relief - Diphenhydramine HCl 25 mg

Manufacturer
Farmacias De Similares TX LLC | Elysium Pharmaceuticals Ltd | Green Star Labs, Inc.
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:37

Label at a glance#

ProductDr. Simi Allergy Relief
Active ingredientDIPHENHYDRAMINE HCL
Label structure10 sections

Indications and uses

■ Temporarily relieves these symptoms due to hay fever, common cold or other respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat ■ Temporarily relieves these symptoms due to the common cold: ■ runny nose ■ sneezing

Dosage and administration

■ Take every 4 to 6 hours or as directed by a doctor ■ Do not take more than 6 times in 24 hours Adults and children 12 years and over 1 to 2 tablets Children 6 years to under 12 years 1 tablet Children under 6 years Do not use

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves these symptoms due to hay fever, common cold or other respiratory allergies:
■ sneezing ■ runny nose ■ itchy, watery eyes
■ itching of the nose or throat
■ Temporarily relieves these symptoms due to the common cold:
■ runny nose ■ sneezing

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

■ with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

■ Take every 4 to 6 hours or as directed by a doctor
■ Do not take more than 6 times in 24 hours

Adults and children 12 years and over

1 to 2 tablets

Children 6 years to under 12 years

1 tablet

Children under 6 years

Do not use

Other information

OTHER SAFETY INFORMATION

■ Each tablet contains: calcium 24 mg
■ Store at 20°–25°C (68°–77°F)
■ Avoid high humidity. Protect from moisture and light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Opadry II 85G54006 Pink.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

NDC: 85786-202-24

DR. SIMI

Allergy Relief

Diphenhydramine HCl 25 mg

Relieves: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat

24 Tablets

Compare to the active ingredient in Benadryl® Allergy†

†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy.

Distributed in USA by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelingCarton labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-202-24Dr. Simi Allergy Relief12 in 1 BLISTER PACKTABLET121
85786-202-24Dr. Simi Allergy Relief2 in 1 CARTONTABLET21

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-20285786-202-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
ndc (package): 85786-202-24
ndc (product): 85786-202
ndc11 (package): 85786020224
spl id: 4fe8bbe3-13ca-5458-e063-6294a90a9064
spl set id: 4fe8bbe3-13c9-5458-e063-6294a90a9064

Reported adverse events (FAERS/openFDA)#

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