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
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 23:04:58
Label at a glance#
ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections
Dosage and administration
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.
Storage and handling
each 5 mL contains: sodium 14 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- a sodium-restricted diet
Ask a doctor or pharmacist before use if the child is
taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- 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
- 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 information
- each 5 mL contains: sodium 14 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, D&C red no 33, FD & C red no.40, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
Questions or comments?
1-855-274-4122
* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Benadryl® Allergy Liquid.
Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Container Label (236 mL Bottle)
NDC 58602-500-20
PrimaryHealth
COMPARE TO Children’s
Benadryl® Allergy Liquid
active ingredient*
Children's
ALLERGY
LIQUID MEDICATION
ANTIHISTAMINE
Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution
Relieves:
- Runny nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat
Alcohol Free
Cherry Flavored Liquid
8 FL OZ (236 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ Container Carton Label (236 mL Bottle)
NDC 58602-500-20
PrimaryHealth
COMPARE TO Children’s
Benadryl® Allergy Liquid
active ingredient*
Children's
ALLERGY
LIQUID MEDICATION
ANTIHISTAMINE
Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution
Relieves:
- Runny nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Throat
Alcohol Free
Cherry Flavored Liquid
8 FL OZ (236 mL)
Products#
Every source-derived product name is available through these pages.
- Childrens Allergy
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ANHYDROUS CITRIC ACID
- D&C RED NO. 33
- FD&C RED NO. 40
- CHERRY
- HIGH FRUCTOSE CORN SYRUP
- POLOXAMER 407
- WATER
- SODIUM BENZOATE
- SODIUM CHLORIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-500 | 58602-500-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| CHERRY | BUC5I9595W | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| 55d03489-3bd3-46f3-a2ee-a1e1d81c3a49 | da11e428-aa5f-4874-89d7-930d3485cc4a | 2020-11-27 | Warnings | 55d03489-3bd3-46f3-a2ee-a1e1d81c3a49 da11e428-aa5f-4874-89d7-930d3485cc4a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.