FDA.reportPublic FDA data

Fridababy Children Allergy Relief Diphenhydramine HCl 12.5mg per 5mL vial , 15ct

Manufacturer
Fridababy LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:17:38

Label at a glance#

ProductFridababy Children Allergy Relief Diphenhydramine HCl 12.5mg per 5mL vial , 15ct
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ give the recommended number of vials below following the instructions: 1. Tap the vial to eliminate air bubbles; 2. Twist the top of the vial off; 3. Squeeze the liquid into child’s mouth. ■ empty each Single Use Vial required of all liquid when dosing. ■ do not give more than 6 doses in 24 hours Dosing chart Age (years) Dose 6-11 year...

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

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 the child has

OTC - ASK DOCTOR SECTION

■ a breathing problem such as chronic bronchitis

■ glaucoma

■ a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ this product does not contain directions or complete warnings for adult use

■ give the recommended number of vials below following the instructions: 1. Tap the vial to eliminate air bubbles; 2. Twist the top of the vial off; 3. Squeeze the liquid into child’s mouth.

■ empty each Single Use Vial required of all liquid when dosing.

■ do not give more than 6 doses in 24 hours

Dosing chart

Age (years)Dose
6-11 years1-2 Single Use Vial (5 mL each) every 4 – 6 hours. Do not exceed 12 vials in 24 hours

Other Information

OTHER SAFETY INFORMATION

■ Each Single Use Vial contains 16mg of sodium

■ Store at 68-77°F (20-25°C)

■ Tamper Evident: do not use if top flap of carton is open. Do not use if any vial is open or broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

1-833-WTF-FRIDA (1-833-983-3743)

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDPDrug Facts LabelDrug Facts Label

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72705-12572705-125-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
GLYCERINPDC6A3C0OXIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

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
0cdef68f-49bf-c3f7-e063-6394a90a9e04e42e5218-e36d-332a-e053-2995a90a029b2023-12-19WarningsExact identifier
spl id: 0cdef68f-49bf-c3f7-e063-6394a90a9e04
spl set id: e42e5218-e36d-332a-e053-2995a90a029b

Reported adverse events (FAERS/openFDA)#

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