Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold.
Pentrexcilina Severe Allergy
- Manufacturer
- OPMX LLC | Health Pharma USA LLC
- Effective date
- 2024-05-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:52
Label at a glance#
ProductPentrexcilina Severe Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and over 1 or 2 caplets children 6 to under 12 years 1 caplet children under 6 years do not use
Storage and handling
each tablet contains: calcium 23.52 mg store at controlled room temperature 20-25°C (68-77°F). read all product information before using Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Diphenhydramine HCl 25 mg
Purpose
| Active ingredient (in each tablet) | Purpose |
| Diphenhydramine HCl 25mg | Antihistamine |
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold.
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask a doctor before use if you have
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 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. Prompt medical attention is critical for adults as well as for children even if you not notice ant signs or symptoms.
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| adults and children 12 years and over | 1 or 2 caplets |
| children 6 to under 12 years | 1 caplet |
| children under 6 years | do not use |
Other information
- each tablet contains:calcium 23.52 mg
- store at controlled room temperature 20-25°C (68-77°F).
- read all product information before using
- Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Inactive ingredients
Colloidal silicon dioxide, Croscarmellose Sodium, D&C red no. 27 aluminum lake, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, talc
Questions or comments?
call (619) 600-5632
Monday through Friday 9AM - 5PM EST
PRINCIPAL DISPLAY PANEL
NDC 69729-106-30
Diphenhydramine HCL 25mg/Antihistamine
Pentrexcilina®
SEVERE ALLERGY
Itchy, Watery Eyes - Picazón y lagrimeo en los ojos
Sneezing - Estornudo
Itchy Throat - Picazón en la garganta
Runny Nose - Escurrimiento Nasal
30 CAPLETS
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 69729-106-30 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2772-fb37-e063-e6dba90a4e07 | Pentrexcilina Severe Allergy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-106-30 | Pentrexcilina Severe Allergy | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 69729-106-30 | Pentrexcilina Severe Allergy | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Pentrexcilina Severe Allergy
- Diphenhydramine Hydrochloride
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- D&C RED NO. 27
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- LECITHIN, SOYBEAN
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYVINYL ALCOHOL, UNSPECIFIED
- TITANIUM DIOXIDE
- DIPHENHYDRAMINE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-106 | 69729-106-30 |
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 |
|---|---|---|---|---|---|---|
| 18afd818-0b54-eb17-e063-6394a90adfac | 18afd818-0b53-eb17-e063-6394a90adfac | 2024-05-17 | Warnings | 18afd818-0b54-eb17-e063-6394a90adfac 18afd818-0b53-eb17-e063-6394a90adfac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.