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
Dye-Free Childrens ALLERGY
- Manufacturer
- Aurohealth LLC
- Effective date
- 2020-11-27
- Label type
- Human OTC Drug Label
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:04:56
Label at a glance#
ProductDye-Free Childrens ALLERGY
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 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 mL = milliliter Age (yr) Dose (mL) children under 6 years of age ask a doctor children 6 years to under 12 years of age 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.
Storage and handling
each 5 mL contains: sodium 9 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient [in each 5 mL]
Diphenhydramine HCl, USP 12.5 mg
Purpose
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
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if the child has
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you
are taking sedatives or tranquilizers
When using this product
- sedatives and tranquilizers may increase drowsiness
- marked drowsiness may occur
- excitability may occur, especially in children
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)
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
- mL = milliliter
| Age (yr) | Dose (mL) |
| children under 6 years of age | ask a doctor |
| children 6 years to under 12 years of age | 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 information
- each 5 mL contains: sodium 9 mg
- store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
- see bottom panel for lot number and expiration date
Inactive ingredients
anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution
Questions or Comments?
1-855-274-4122
* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Dye Free Allergy.
Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Label (118 mL Bottle)
NDC 58602-501-24
PrimaryHealth
COMPARE TO children’s
Benadryl® active
ingredient*
Dye-Free Children's
ALLERGY
LIQUID MEDICATION
ANTIHISTAMINE
Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution
Relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat
Sugar &
Alcohol Free
Dye-Free
Bubble Gum Flavored
4 FL OZ (118 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Carton Label (118 mL Bottle)
NDC 58602-501-24
PrimaryHealth
COMPARE TO children’s
Benadryl® active
ingredient*
Dye-Free Children's
ALLERGY
LIQUID MEDICATION
ANTIHISTAMINE
Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution
Relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat
Sugar &
Alcohol Free
Dye-Free
Bubble Gum Flavored
4 FL OZ (118 mL)
Products#
Every source-derived product name is available through these pages.
- Dye-Free Childrens ALLERGY
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ANHYDROUS CITRIC ACID
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- GLYCERIN
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-501 | 58602-501-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| 65298db6-d550-45da-a579-248966f7540f | bb5f9226-cf5b-491d-a329-030f70d1218f | 2020-11-27 | Warnings | 65298db6-d550-45da-a579-248966f7540f bb5f9226-cf5b-491d-a329-030f70d1218f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.