FDA.reportPublic FDA data

DIPHENHYDRAMINE HCl Tablets, USP 25mg

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2022-02-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:48:33

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, not more than 6 doses in 24 hours Adults and children 12 years of age and older: 1 or 2 tablets children 6 to under 12 years of age: 1 tablet children 4 to under 6 years of age: do not use unless directed by a doctor children under 4 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

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
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

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

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

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • 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

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 accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  • Adults and children 12 years of age and older: 1 or 2 tablets
  • children 6 to under 12 years of age: 1 tablet
  • children 4 to under 6 years of age: do not use unless directed by a doctor
  • children under 4 years of age: do not use

Other Information

OTHER SAFETY INFORMATION

  • each tablet contains : calcium 20 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc

Questions or Comments

OTC - QUESTIONS SECTION

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE TABLET

, USP 25 MG

ANTIHISTAMINE

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Benadryl� Allergy.

71309-109-10 100 Caplets

100 ct100 ct

71309-109-06 600 Caplets

600 ct600 ct

71309-109-01 1000 Caplets

1000 ct1000 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4

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
71309-009-012024-01-30C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg
71309-009-062024-01-30C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg
71309-009-102024-01-30C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg
71309-009-302024-01-30C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg
71309-009-102022-02-27C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg
71309-009-102022-01-28C16284748780-1d6a99b39-c9c3-a426-e053-dadaa90af4c2DIPHENHYDRAMINE HCl Tablets, USP 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-009-01Allergy Relief1000 in 1 BOTTLETABLET10004
71309-009-06Allergy Relief600 in 1 BOTTLETABLET6004
71309-009-10Allergy Relief100 in 1 BOTTLETABLET1004
71309-009-30Allergy Relief1 in 1 CARTONTABLET14
71309-009-30Allergy Relief30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-009ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SAFREL PHARMACEUTICALS, LLC.]4Legacy NDC, 5 package rows20220228_872a82a1-af9a-7b0a-e053-2a91aa0ac0df.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-00971309-009-30, 71309-009-10, 71309-009-01, 71309-009-06

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYVINYL ALCOHOL532B59J990IACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
d9065098-5108-90c8-e053-2995a90a7e85872a82a1-af9a-7b0a-e053-2a91aa0ac0df2022-02-27WarningsExact identifier
spl id: d9065098-5108-90c8-e053-2995a90a7e85
spl set id: 872a82a1-af9a-7b0a-e053-2a91aa0ac0df

Reported adverse events (FAERS/openFDA)#

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