Allergy Antihistamine Capsules

Manufacturer
KROGER COMPANY
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:35

Label at a glance#

ProductAllergy Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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 do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use

Storage and handling

store at room temperature between 20-25 °C (68-77 °F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each banded capsule)

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

OTC - DO NOT USE SECTION

  • to make a 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
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature between 20-25 °C (68-77 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate 80, propylparaben, purified water, sodium lauryl sulphate, starch

Questions or comments

OTC - QUESTIONS SECTION

1-800-632-6900

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of BENADRYL® *See bottom panel

NDC 30142-832-84

Kroger®

Allergy
Capsules

Diphenhydramine HCl
25 mg
ANTIHISTAMINE

OUR PHARMACIST RECOMMENDED

actual
size

TEMPORARILY
RELIEVES:
Sneezing Runny Nose
Itchy, Watery Eyes
Itchy Throat

100 CAPSULES

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton
PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

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
30142-832-48Allergy Antihistamine4 in 1 CARTONCAPSULE43
30142-832-48Allergy Antihistamine12 in 1 BLISTER PACKCAPSULE123
30142-832-84Allergy Antihistamine100 in 1 BOTTLECAPSULE1003
30142-832-84Allergy Antihistamine1 in 1 CARTONCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-832ALLERGY ANTIHISTAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [KROGER COMPANY]3Current NDC, Legacy NDC, 4 package rows20240119_af5053d8-ba02-4cdf-877f-8c1e368dafe0.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
30142-83230142-832-48, 30142-832-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
ndc (package): 30142-832-48
ndc (package): 30142-832-84
ndc (product): 30142-832
ndc11 (package): 30142083248
ndc11 (package): 30142083284
spl id: 936eaefd-c100-4239-8679-8cb5618daf66
spl set id: af5053d8-ba02-4cdf-877f-8c1e368dafe0

Reported adverse events (FAERS/openFDA)#

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