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#
Contacts and useful links#
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 Label
Allergy 100ct Carton
Allergy 100ct label
Allergy 24ct Carton
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41226-160-01 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
| 41226-160-40 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
| 41226-160-42 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
| 41226-160-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
| 41226-160-40 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
| 41226-160-42 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-afaf-d83d-e063-dadaa90ab31f | 160R KROGER 41226 160 Diphenhydramine Hydrochloride Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-160-01 | ALLERGY | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 | |
| 41226-160-01 | ALLERGY | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 4 | |
| 41226-160-40 | ALLERGY | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | 4 | |
| 41226-160-40 | ALLERGY | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 | |
| 41226-160-42 | ALLERGY | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 4 | |
| 41226-160-42 | ALLERGY | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
Products#
Every source-derived product name is available through these pages.
- ALLERGY
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- POLYSORBATE 80
- TITANIUM DIOXIDE
- HYPROMELLOSES
- POLYETHYLENE GLYCOL 400
- DIPHENHYDRAMINE
- MAGNESIUM STEARATE
- CROSCARMELLOSE SODIUM
- CARNAUBA WAX
- SILICON DIOXIDE
- D&C RED NO. 27 ALUMINUM LAKE
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-160 | 41226-160-42, 41226-160-40, 41226-160-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kroger Company | bc019c9e-8fac-5fd3-e053-2a95a90a7ccd | 2025-06-25 | Warnings | 41226-160-42 41226-160-01 41226-160-40 41226-160 41226016042 41226016040 41226016001 3860490c-68ee-ea49-e063-6394a90af03a bc019c9e-8fac-5fd3-e053-2a95a90a7ccd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




