FDA.reportPublic FDA data

FirstCare Childrens Allergy Diphenhydramine HCl Chewable Gels

Manufacturer
USpharma Ltd
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:33:12

Label at a glance#

ProductFirstCare Childrens Allergy Diphenhydramine HCl Chewable Gels
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

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Instruct child to chew each chewable gel thoroughly before swallowing find right dose on chart below Age (yr) Dose (chewable gels) 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 1 to 2 chewable gels (12.5 mg to 25 mg) Adults and children 12 years and o...

Label contents#

Full prescribing information#

Active ingredient (in each chewable gel)

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

  • To make 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
  • Instruct child to chew each chewable gel thoroughly before swallowing
  • find right dose on chart below

    Age (yr)

    Dose (chewable gels)

    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

    1 to 2 chewable gels (12.5 mg to 25 mg)

    Adults and children 12 years and over

    2 to 4 chewable gels (25 mg to 50 mg)

SPL UNCLASSIFIED SECTION

Other information

  • each chewable gel: contains sodium 7 mg.
  • store in a cool dry place between 20-25°C (68-77°F).

Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

trisodium citrate dihydrate, sodium chloride, sucralose, neotame, glucose syrup, seaweed extract (carrageenan), maltitol solution, hydroxypropyl betadex, maltodextrin, flavor, sucrose, mineral oil, starch, citric acid, purified water.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-800-227-6151

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRST CARETM

***MADE IN USA***

CHILDEREN'S ALLERGY RELIEF

Diphenhydramine HCl Anthihistamine 12.5 mg Chewable Gels

  • Runny Nose & Sneezing
  • Itchy throat or Nose
  • Itchy, Water Eyes

14 Bubble Gum Flavored Gummies NDC 71594-700-04

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71594-70071594-700-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SODIUM CHLORIDE451W47IQ8XIACT
SUCRALOSE96K6UQ3ZD4IACT
NEOTAMEVJ597D52EXIACT
CORN SYRUP9G5L16BK6NIACT
CARRAGEENAN5C69YCD2YJIACT
MALTITOLD65DG142WKIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
MINERAL OILT5L8T28FGPIACT
STARCH, CORNO8232NY3SJIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML · Source PDF

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
a68d0b47-3e30-7bb9-e053-2a95a90a85f96caf6ec5-8486-4deb-9d44-ea387f7134162020-05-26WarningsExact identifier
spl set id: 6caf6ec5-8486-4deb-9d44-ea387f713416

Reported adverse events (FAERS/openFDA)#

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