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

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

Drug Labeling and Warnings

Fridababy Children Allergy Relief Diphenhydramine HCl 12.5mg per 5mL vial , 15ct by is a Otc medication manufactured, distributed, or labeled by Fridababy LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRIDABABY CHILDREN ALLERGY RELIEF DIPHENHYDRAMINE HCL 12.5MG PER 5ML VIAL , 15CT- diphenhydramine hcl 12.5mg / 5ml solution 
Fridababy LLC

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

Active Ingredient (in each 5mL)

Diphenhydramine HCL 12.5mg

Purpose

Antihistamine

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.

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 the child has

■ a breathing problem such as chronic bronchitis

■ glaucoma

■ a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

taking any sedatives or tranquilizers

When using this product

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ sedatives and tranquilizers may increase the drowsiness effect

Keep out of reach of children

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

Directions

■ 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 years: 1-2 Single Use Vial (5 mL each) every 4 – 6 hours. Do not exceed 12 vials in 24 hours

Other 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

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

Questions or Comments?

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

Package

FRIDABABY CHILDREN ALLERGY RELIEF DIPHENHYDRAMINE HCL 12.5MG PER 5ML VIAL , 15CT 
diphenhydramine hcl 12.5mg / 5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-125-15	15 in 1 POUCH	08/16/2022
1		5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/16/2022	07/31/2024

Labeler - Fridababy LLC (783729598)

Revised: 12/2023

Document Id: 0cdef68f-49bf-c3f7-e063-6394a90a9e04

34390-5

Set id: e42e5218-e36d-332a-e053-2995a90a029b

Version: 4

Effective Time: 20231219