REVASOL CHILDRENS ALLERGY- diphenhydramine hcl liquid

REVASOL CHILDRENS ALLERGY by

Drug Labeling and Warnings

REVASOL CHILDRENS ALLERGY by is a Otc medication manufactured, distributed, or labeled by Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 5 mL) Purpose
Diphenhydramine HCl 12.5mg..........................................................Antihistamine

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat

WARNINGS

Warnings

Do not use to make a child sleepy with any other product containing diphenhydramine, even on one used on skin

ASK DOCTOR

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis glaucoma

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

WHEN USING

When using this product

marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

find the right dose on chart below
mL=mililiter take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

• Age: Dose
• children 6 to 11 years: 5 mL to 10 mL
• children 2 to 5 years: do not use unless directed by a doctor
• children under 2 years: do not use

OTHER SAFETY INFORMATION

Other information
each 5 mL contains: sodium 4 mg
store between 15-30°C (59-86°F).
TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing.

INACTIVE INGREDIENT

Inactive ingredients

anhydrous citric acid, D&C Red #33, FD&C Red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium
citrate, sorbitol solution, sucralose.

QUESTIONS

Questions or comments 1-888-446-4753
Monday - Friday (9 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVASOL CHILDRENS ALLERGY 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84379-286
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
MENTHOL (UNII: L7T10EIP3A)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84379-286-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/12/2025

Labeler - Rnv LLC (118917568)

Registrant - Rnv LLC (118917568)

Establishment
Name	Address	ID/FEI	Business Operations
Rnv LLC		118917568	manufacture(84379-286)