Indications and uses
▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ▪ runny nose ▪ itchy, watery eyes ▪ sneezing ▪ itching of the nose or throat
TOPCO Children’s Allergy Chews
- Manufacturer
- Topco Associates, LLC
- Effective date
- 2026-11-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-11-14 03:02:24
Label at a glance#
ProductTOPCARE Childrens Allergy Chews
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
▪ find right dose on chart below ▪ Chew one tablet completely at the onset of symptoms. Do not swallow tablets whole. ▪ take every 4 to 6 hours or as directed by a doctor ▪ do not take more than 6 times in 24 hours Age (Year) Dose (Chewable tablets) 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 of age 1 to 2 chewable tablets (12.5 mg to 25 ...
Storage and handling
▪ each chewable tablet contains : sodium 3 mg ▪ store at room temperature. Avoid high humidity. Protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each chewable tablet)
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.
- runny nose
- itchy, watery eyes
- sneezing
- 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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222
Directions
- find right dose on chart below
- Chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
- take every 4 to 6 hours or as directed by a doctor
- do not take more than 6 times in 24 hours
Age (Year) | Dose (Chewable tablets) |
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 of age | 1 to 2 chewable tablets (12.5 mg to 25 mg) |
adults and children 12 years of age and over | 2 to 4 tablets (25 mg to 50 mg) |
Other information
- each chewable tablet contains : sodium 3 mg
- store at room temperature. Avoid high humidity. Protect from light
Inactive ingredients
citric acid, crospovidone, D&C Red No. 30, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.
Questions or comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredient in Children's Benadryl® Allergy Chewable Tablets*
NDC 76162-201-20
Children’s Allergy Chews
Diphenhydramine HCl, / Antihistamine
For Relief of:
- sneezing
- runny nose
- itchy throat or nose
- itchy, watery eyes
4-6 Hours/Dose
Grape Flavor
Naturally and Artificially Flavored
20 Chewable Tablets
TAMPER EVIDENT: DO NOT USE IF CARTON OR IF BLISTER UNIT IS BROKEN OR OPEN.
*This product is not manufactured or distributed by Kenvue INC., owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets*.
Distributed by:
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| a90f088a-9578-47a2-8f6e-0a9d32aafec6 | Product name | 1 | 20181030 |
| f6c90bdc-1674-455a-aadd-1b1b59e5edeb | Product name | 2 | 20181030 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| f1ec5c2f-d01e-a277-5826-c7eba86ed99b | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- TOPCARE Childrens Allergy Chews
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CITRIC ACID MONOHYDRATE
- CROSPOVIDONE (120 .MU.M)
- D&C RED NO. 30
- DEXTROSE, UNSPECIFIED FORM
- FD&C BLUE NO. 1
- MAGNESIUM STEARATE
- MALTODEXTRIN
- POTASSIUM CITRATE
- SILICON DIOXIDE
- SODIUM POLYSTYRENE SULFONATE
- STARCH, CORN
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-201 | 76162-201-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-11-08 | full-release | 2026-06-01 01:42:56 |
| 1 | 2025-06-10 | full-release | 2026-06-01 01:02:47 |
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 |
|---|---|---|---|---|---|---|
| TOPCARE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | Topco Associates, LLC | b5e15dd1-6e99-411c-9183-8a4265eae404 | 2025-11-08 | Warnings | 76162-201-20 76162-201 76162020120 b5e15dd1-6e99-411c-9183-8a4265eae404 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.