Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet) Diphenhydramine HCl 25 mg
OTC - PURPOSE SECTION
Purpose Antihistamine
160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
- Manufacturer
- WALGREENS | 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 01:03:58
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
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
Warnings
WARNINGS SECTION
Warnings
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions Take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years of age and over: 1 to 2 caplets children 6 to under 12 years of age: 1 caplet children under 6 years of age: do not use
Other Label Information
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 dioxide
Label Images#
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 |
|---|---|---|---|---|---|
| 0363-0100-61 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-5cb6-d83d-e063-dadaa90ab31f | 160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets |
| 0363-0100-65 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-5cb6-d83d-e063-dadaa90ab31f | 160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets |
| 0363-0100-61 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5cb6-d83d-e063-dadaa90ab31f | 160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets |
| 0363-0100-65 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5cb6-d83d-e063-dadaa90ab31f | 160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0100-61 | ALLERGY RELIEF | 600 in 1 BOTTLE | TABLET, FILM COATED | 600 | 4 | |
| 0363-0100-65 | ALLERGY RELIEF | 365 in 1 BOTTLE | TABLET, FILM COATED | 365 | 4 |
Products#
- ALLERGY RELIEF
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0100 | 0363-0100-65, 0363-0100-61 |
Ingredients#
Complete SPL Sections#
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet) 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 Itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing
WARNINGS SECTION
Warnings
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, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years of age and over: 1 to 2 caplets children 6 to under 12 years of age: 1 caplet children under 6 years of age: do not use
OTHER SAFETY INFORMATION
Other information each caplet contains: calcium 25 mg protect from light Store between 20-25°C (68-77° 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 dioxide