FDA.reportPublic FDA data

PhysiciansCare Allergy

Manufacturer
Acme United Corporation
Effective date
2024-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:36

Label at a glance#

ProductPhysiciansCare Allergy Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg

OTC - PURPOSE SECTION

Purpose


Antihistamine

INDICATIONS & USAGE SECTION

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies

  • runny nose
  • sneezing
  • itching nose or throat
  • itchy-watery eyes

temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one that is used on the skin.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficuly in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product
* marked drowsiness may occur and avoid alcoholic beverages
* alcohol, sedatives and tranquilizers may increase the drowsiness effect
* use caution when driving a motor vehicle or operating machinery
* excitability may occur, especially in children

If pregnant or breast feeding, ask a health professional

before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Do not use more than directed


Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

INFORMATION FOR PATIENTS SECTION

Other information

  • each caplet may contain: calium 25mg
  • store at room temperature 59°-86°F (15°-30°C)
  • protect from light
  • use by expiration date on packet
  • tamper-evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients


carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide



*may contain.

OTC - QUESTIONS SECTION

Questions?

1-800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOX16790056-revC.jpg

Carton 167Carton 167

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton184Carton184Box18490036-revC.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
0924-0056-01PhysiciansCare AllergyAntihistamine50 in 1 CARTONTABLET, FILM COATED502
0924-0056-01PhysiciansCare AllergyAntihistamine1 in 1 PACKETTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0056PHYSICIANSCARE ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241211_5e31b1ff-291f-7b8c-e053-2a91aa0aedbc.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-00560924-0056-01
47682-167

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CARNAUBA WAXR12CBM0EIZIACT
POLYETHYLENE GLYCOL 2000HAF0412YITIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
POLYSORBATE 806OZP39ZG8HIACT
D&C RED NO. 272LRS185U6KIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
ndc (product): 47682-167
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
ndc (package): 0924-0056-01
ndc (product): 0924-0056
ndc11 (package): 00924005601
spl id: 26809b6a-0bd9-752f-e063-6394a90ab5e9
spl set id: 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc

Reported adverse events (FAERS/openFDA)#

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