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
Diphenhydramine HCl 12.5mg Antihistamine
- Manufacturer
- Alexso, Inc
- Effective date
- 2021-02-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:51:11
Label at a glance#
ProductDiphenhydramine HCl 12.5mg Antihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections
Dosage and administration
Adults and children 12 years and over: Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallowing Children 6 to 11 years: Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor. Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallo...
Storage and handling
each soft chew contains: sodium 7 mg . Very low sodium. store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Diphenhydramine HCl 12.5 mg Soft Chews
Alexso, Inc.
----------------
Diphenhydramine HCl 12.5 mg Soft Chews
DRUG FACTS
ACTIVE INGREDIENT (in each soft chew)
Diphenhydramine HCl 12.5mg
PURPOSE
Antihistamine
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
WARNINGS
Do not use
- To make child sleepy
- With any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
- Trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers
When using this product
- Excitability may occur, especially in children
- Marked drowsiness may occur
- Avoid alcoholic drinks
- Alcohol, sedatives, and tranquilizers may increase drowsiness
- Be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DIRECTIONS
Adults and children 12 years and over:
- Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor
- Do not take more than 6 times in 24 hours
- Chew each soft chew thoroughly before swallowing
Children 6 to 11 years:
- Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor.
- Do not take more than 6 times in 24 hours
- Chew each soft chew thoroughly before swallowing
Children under 6 years: Do not use
OTHER INFORMATION
- each soft chew contains: sodium 7
mg. Very low sodium.
- store in a cool dry place between 20-25°C (68-77°F).
- Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive ingredients:
citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
Questions or comments?
Call 888-495-6078
HOW SUPPLIED
Diphenhydramine 12.5mg Soft Chews is supplied in the following dosage form:
Twenty (20) Soft Chews per container
***Made in USA***
Manufactured for:
Alexso, Inc.
2317 Cotner Ave
Los Angeles, CA 90064
NDC: 50488-4125-1
Size: 20 Soft Chews
PRINCIPAL DISPLAY PANEL
Diphenhydramine HCl 12.5 mg Soft Chews
20 Bubble Gum Flavored Gummies
Chewy Gummy Bites
NDC: 50488-4125-1 Patent Pending
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-4125-1 | EA - Each | 50488-4125 | 509cf92a-4529-427a-9cdd-5076e36af3a1 | 1 | 2021-05-05 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine HCl 12.5mg Antihistamine
- Diphenhydramine Hydrochloride
- DIPHENHYDRAMINE
- CITRIC ACID MONOHYDRATE
- ANHYDROUS DEXTROSE
- HYDROXYPROPYL BETADEX
- MAGNESIUM STEARATE
- MALTITOL
- MALTODEXTRIN
- MINERAL OIL
- NEOTAME
- WATER
- CARRAGEENAN
- SODIUM CHLORIDE
- STARCH, CORN
- CORN SYRUP
- SUCRALOSE
- SUCROSE
- TRISODIUM CITRATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50488-4125 | 50488-4125-1 |
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 |
|---|---|---|---|---|---|---|
| 801d50c1-d2ef-4c14-8843-9be29507aa26 | 41b6e96a-9fce-4aa2-9eeb-3a5bd5f7af41 | 2024-11-27 | Warnings | 41b6e96a-9fce-4aa2-9eeb-3a5bd5f7af41 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.