Childrens Allergy Relief
- Manufacturer
- Plastikon Healthcare, LLC
- Effective date
- 2021-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:22:19
Label at a glance#
ProductChildrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure1 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Diphenhydramine HCl 12.5 mg / 5 mL Vial/Ampoule
Single use measurements
for easy accurate dosing
*compare to the active ingredients in children's Benadryl® allergy liquid
CORRECTDOSE
Precise - Portable - Single-Use
Children's
ALLERGY
RELIEF
Diphenhydramine HCl
Oral solution Antihistamine
Cherry
12
Pre-Filled
Single Use
Doses
Relieves
Sneezing, Running Nose,
Itchy & Watery Eyes,
Itchy Throat
12.04 FL. OZ (60 mL)
12 - 5 mL Individual Doses
Diphenhydramine HCl 12.5 mg/ 5 mL
Warnings
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin
• if hypersensitive to diphenhydramine HCl and other similar antihistamines
___________________________________________________________________
Ask a doctor before use if you have
• glaucoma • a breathing problem such as emphysema or chronic bronchitis
• a sodium restricted diet
___________________________________________________________________
Ask a doctor or pharmacist before use if
• the child is taking tranquilizers or sedatives
___________________________________________________________________
When using this product
• marked drowsiness may occur
• sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
Diphenhydramine HCl 12.5 mg/ 5 mL
Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose
Diphenhydramine HCl 12.5 mg / 5 mL
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat
Diphenhydramine HCl 12.5 mg/ 5 mL
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)
Diphenhydramine HCl 12.5 mg/ 5 mL
Antihistamine
Diphenhydramine HCl 12.5 mg/ 5 mL
Active ingredient (in each 5 mL unit)
Diphenhydramine HCl USP 12.5 mg
Diphenhydramine HCl 12.5 mg/ 5 mL
• each 5 mL contains: sodium 15 mg
- store at 20-25°C (68-77°F)
- do not use if foil seal is opened/damaged
- see bottom of bag for lot number and expiration date
- protect from excessive moisure
- sugar free, dye free, alcohol free
Children's Allergy Relief Diphenhydramine 12.5 mg/5 mL Single Use Pouch
CORRECTDOSE
Precise - Portable - Single-Use
Children's
ALLERGY
RELIEF
Diphenhydramine HCl
Oral Solution
Antihistamine
Cherry
Relieves
Sneezing, Runny Nose,
Itchy & Watery Eyes,
Itchy Throat
1
Pre-Filled
Single-Use
Dose
Lasts up to
6 hours
WARNING
Choking Hazard
- Small parts
Keep out of reach
of small children
0.17 FL. OZ (5 mL)
Diphenhydramine HCl 12.5 mg/ 5 mL
Directions
- Do not exceed 6 doses (12 vials) in a 24 hour period
- give the recommended number of vials below following the instructions under How to Use on the back panel
- empty each single-use vial required, of all liquid when dosing
- this product does not contain directions or complete warnings for adult use
Age (yr) | Dose (mL) |
6-11 years | 1-2 Single-use vials (5 mL each) every 4-6 hours Do not exceed 6 doses (12 vials) in a 24 hours |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62320-302-05 | 2022-09-23 | C162847 | 48780-1 | e4f33bdf-afe0-d8a0-e053-dadaa90a6e4e | Children's Allergy Relief 5 mL vial/ampoule Correct Dose |
| 62320-302-05 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-afe0-d8a0-e053-dadaa90a6e4e | Children's Allergy Relief 5 mL vial/ampoule Correct Dose |
Products#
Every source-derived product name is available through these pages.
- Childrens Allergy Relief
- Diphenhydramine hydrochloride
- ANHYDROUS CITRIC ACID
- AMMONIUM GLYCYRRHIZATE
- SUCRALOSE
- SODIUM CHLORIDE
- TRISODIUM CITRATE DIHYDRATE
- POLOXAMER 407
- GLYCERIN
- SODIUM BENZOATE
- WATER
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62320-302 | 62320-302-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| WATER | 059QF0KO0R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| e95f150e-3c73-7cb8-e053-2a95a90a9cb4 | c0e3b0ad-8044-4b4e-e053-2995a90a50a3 | 2022-09-23 | Warnings | c0e3b0ad-8044-4b4e-e053-2995a90a50a3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.