Diphenhydramine HCl 12.5 mg per 5 mL Oral Solution Dye Free - Bubblegum Flavor
- Manufacturer
- BETTER LIVING BRANDS LLC. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-10-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-11-13 02:01:57
Label at a glance#
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
Diphenhydramine HCl 12.5mg / 5 ml Label
Diphenhydramine HCL 12.5mg / 5 ml Carton
Products#
Every source-derived product name is available through these pages.
- CHILDRENS DYE FREE ALLERGY RELIEF
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SACCHARIN SODIUM
- SUCRALOSE
- SORBITOL SOLUTION
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- ANHYDROUS CITRIC ACID
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21130-558 | 21130-558-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

