FDA.reportPublic FDA data

Allergy

Manufacturer
Mechanical Servants, LLC
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:39

Label at a glance#

ProductAllergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies sneezing nasal congestion runny nose itchy, watery eyes Temporarily relieves these symptoms due to 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 doses in 24 hours adults and children 12 years and over         1 to 2 tablets children 6 to under 12 years                       1 tablet children under 6 years                               ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Diphenhydramine HCl (25 mg)

OTC - PURPOSE SECTION

Antihistamine

Warnings

WARNINGS SECTION

Do not use

  • to make a child sleepy
  • with any other product containing Diphenhydramine, even one used on the skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • 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 the 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over         1 to 2 tablets

children 6 to under 12 years                       1 tablet

children under 6 years                               ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-428-2538

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

Temporarily relieves these symptoms due to common cold

  • runny nose
  • sneezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALLERGY

Diphenhydramine HCI 25mg | Antihistamine

Runny Nose Nasal Congestion

Sneezing Itchy Watery Eyes

COMPARE TO THE ACTIVE INGREDIENTS IN

BENADRYL® *

6 TABLETS

ALLERGYALLERGY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
29485-7007-62023-01-30C16284748780-1ba0f9c33-1152-a910-e053-dadaa90a0b85Allergy
29485-7007-62021-10-06C16284748780-1ba0f9c33-1152-a910-e053-dadaa90a0b85Allergy
29485-7007-62021-01-29C16284748780-1ba0f9c33-1152-a910-e053-dadaa90a0b85Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-7007-6Allergy6 in 1 PACKAGETABLET63
29485-7007-6Allergy2 in 1 POUCHTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-7007ALLERGY (DIPHENHYDRAMINE HCL) TABLET [MECHANICAL SERVANTS, LLC]3Legacy NDC, 2 package rows20211008_a1e4781a-6715-461a-9289-94da68129f4a.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
29485-700729485-7007-6

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
D&C RED NO. 272LRS185U6KIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
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
b450462a-e93f-559e-e053-2a95a90abd17a1e4781a-6715-461a-9289-94da68129f4a2021-10-06WarningsExact identifier
spl id: b450462a-e93f-559e-e053-2a95a90abd17
spl set id: a1e4781a-6715-461a-9289-94da68129f4a

Reported adverse events (FAERS/openFDA)#

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