Albertsons 653L Diphenhydramine HCl 12.5mg Oral Solution
- Manufacturer
- BETTER LIVING BRANDS LLC. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-04-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:55:34
Label at a glance#
ProductChildrens Dye Free Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Diphenhydramine HCl 12.5 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
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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 the child has
- a breathing problem such as chronic bronchitis
- glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
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
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| Age (yr) | Dose (mL) |
| children under 2 years | do not use |
| children 2 to 5 years | do not use unless directed by a doctor |
| children 6 to 11 years | 5 mL to 10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
OTHER SAFETY INFORMATION
Other information
- each 5 mL contains: sodium 5 mg
- store at no greater than 25°C
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, flavors, glycerin, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
653L Children's Dye Free Allergy Relief - Bubblegum flavor - Label
653L Children's Dye Free Allergy Relief - Bubblegum flavor - Carton
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 2 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 2 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 2 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 2 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 2 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-563-05 | Childrens Dye Free Allergy Relief | 1 in 1 CARTON | LIQUID | 1 | 2 | |
| 21130-563-05 | Childrens Dye Free Allergy Relief | 118 mL in 1 BOTTLE | LIQUID | 118 | 2 |
Products#
Every source-derived product name is available through these pages.
- Childrens Dye Free Allergy Relief
- Diphenhydramine HCl
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SACCHARIN SODIUM
- SUCRALOSE
- SORBITOL SOLUTION
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- ANHYDROUS CITRIC ACID
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21130-563 | 21130-563-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| 49d2ed14-991a-65c1-e063-6394a90ac59b | 46d5ec5f-1154-e4de-e063-6394a90a4466 | 2026-04-27 | Warnings | 49d2ed14-991a-65c1-e063-6394a90ac59b 46d5ec5f-1154-e4de-e063-6394a90a4466 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.