FDA.reportPublic FDA data

TOPCARE

Manufacturer
Topco Associates, LLC
Effective date
2025-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:42:56

Label at a glance#

ProductTOPCARE Childrens Allergy Chews
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

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

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 mg) adul...

Storage and handling

each chewable tablet contains : sodium 3 mg store at room temperature. Avoid high humidity. Protect from light

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  •  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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • each chewable tablet contains: sodium 3 mg
  • store at room temperature. Avoid high humidity. Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

  1-866-467-2748

Principal Display Panel

PACKAGE LABEL.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:

TOPCO Childrens allergy Chews 20 counts
TOPCO Childrens allergy Chews 20 counts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN2
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-201-20TOPCAREChildrens Allergy Chews2 in 1 CARTONTABLET, CHEWABLE22
76162-201-20TOPCAREChildrens Allergy Chews10 in 1 BLISTER PACKTABLET, CHEWABLE102

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-20176162-201-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM POLYSTYRENE SULFONATE1699G8679ZIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-10full-release2026-06-01 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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
ndc (package): 76162-201-20
ndc (product): 76162-201
ndc11 (package): 76162020120
spl id: 431146ca-c8d1-8d10-e063-6294a90a4a0c
spl set id: b5e15dd1-6e99-411c-9183-8a4265eae404

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.