FDA.reportPublic FDA data

allergy relief Diphenhydramine HCI 25 mg Antihistamine

Manufacturer
Strategic Sourcing Services LLC | USpharma Ltd
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:49:02

Label at a glance#

Productallergy relief Diphenhydramine HCI 25 mg Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:      runny nose     itchy, watery eyes     sneezing     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 hour                                                                                                                                                    Age (yr) Dose (Piece) Adults and children 12 years and over 1 to 2 Pieces (25 mg to 50 mg) Children 6 to 11 years 1 Piece (25 mg) Children under 6 years Do not use

Label contents#

Full prescribing information#

Active ingredient (in each piece)

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

Warnings

WARNINGS SECTION

Do not use

  • To make child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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 (1-800-222-1222) right away. 

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 hour                                                                                                                                                   

    Age (yr)

    Dose (Piece)

    Adults and children 12 years and over

    1 to 2 Pieces (25 mg to 50 mg)

    Children 6 to 11 years

    1 Piece (25 mg)

    Children under 6 years

    Do not use

SPL UNCLASSIFIED SECTION

Other information

  • each piece contains sodium 9 mg.

    low sodium

  • store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid, FD&C red #40, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate,maltitol solution, maltodextrin, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

Principal display Panel-25 mg carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark

COMPARE TO BENADRYL® ALLERGY active ingredient

NDC 70677-1062-1

Soft Chews

allergy relief Diphenhydramine HCl, 25 mg | Antihistamine

Allergy Relief for:                    

Sneezing                                            

Runny Nose                                       

Itchy, Watery Eyes                          

Itchy Throat 

Bubble Gum Flavor

Chewy Bites

Actual Size         10 PIECES

Principal display Panel-25 mg carton labelPrincipal display Panel-25 mg carton label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0162ALLERGY RELIEF DIPHENHYDRAMINE HCI 25 MG ANTIHISTAMINE (DIPHENHYDRAMINE HCL) BAR, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]2Legacy NDC20241122_e215b97f-22eb-4cef-9e2d-b8a0df660bfc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0162-1EA - Each70677-01624b73baf8-830b-460f-bc34-81c82939e88b12023-02-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-016270677-0162-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
CORN SYRUP9G5L16BK6NIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTITOLD65DG142WKIACT
MALTODEXTRIN7CVR7L4A2DIACT
NEOTAMEVJ597D52EXIACT
WATER059QF0KO0RIACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM CHLORIDE451W47IQ8XIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
46548657-0e80-0166-e063-6394a90a44eae215b97f-22eb-4cef-9e2d-b8a0df660bfc2025-12-19WarningsExact identifier
spl set id: e215b97f-22eb-4cef-9e2d-b8a0df660bfc

Reported adverse events (FAERS/openFDA)#

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