160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets

Manufacturer
Kroger Company | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:57

Label at a glance#

ProductALLERGY
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itchy nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 4 to 6 hours
  • 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 to 2 tablets

children under 6 years

1 to 2 tablets

OTHER SAFETY INFORMATION

Other information

  • each caplet contains: calcium 25 mg
  • protect from light
  • store at 25°C (77°F) excursions permitted 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxidede

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy 400ct Carton

Allergy 400ct CartonAllergy 400ct Carton

Allergy 400ct Label

Allergy 400ct labelAllergy 400ct label

Allergy 100ct Carton

Allergy 100ct CartonAllergy 100ct Carton

Allergy 100ct label

Allergy 100 labelAllergy 100 label

Allergy 24ct Carton

Allergy 24ct CartonAllergy 24ct Carton

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-160-01ALLERGY1 in 1 CARTONTABLET, FILM COATED14
41226-160-01ALLERGY100 in 1 BOTTLETABLET, FILM COATED1004
41226-160-40ALLERGY400 in 1 BOTTLETABLET, FILM COATED4004
41226-160-40ALLERGY1 in 1 CARTONTABLET, FILM COATED14
41226-160-42ALLERGY12 in 1 BLISTER PACKTABLET, FILM COATED124
41226-160-42ALLERGY1 in 1 CARTONTABLET, FILM COATED14

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
41226-16041226-160-42, 41226-160-40, 41226-160-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
ndc (package): 41226-160-42
ndc (package): 41226-160-01
ndc (package): 41226-160-40
ndc (product): 41226-160
ndc11 (package): 41226016042
ndc11 (package): 41226016040
ndc11 (package): 41226016001
spl id: 3860490c-68ee-ea49-e063-6394a90af03a
spl set id: bc019c9e-8fac-5fd3-e053-2a95a90a7ccd

Reported adverse events (FAERS/openFDA)#

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