DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution

Diphenhydramine HCl Oral Solution by

Drug Labeling and Warnings

Diphenhydramine HCl Oral Solution by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Lohxa, Ultrum Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient per 5 mL (1 Unit Dose)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

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

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

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

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

Directions

take every 4 to 6 hours, or as directed by a physician
do not take more than 6 doses in 24 hours

age	dose
Children under 2 years of age	Do not use
Children 2 to under 6 years of age	Do not use unless directed by a doctor
Children 6 to under 12 years of age	5 mL (12.5 mg) to 10 mL (25 mg)

Other information

each 5 mL contains sodium: 3 mg
store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
do not use if lid is torn or broken

Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? Call 1-844-474-7464

SPL UNCLASSIFIED SECTION

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

FG-35/Iss.: 10/2023

NDC Information -

12.5 mg/5 mL

Each 5 mL of Diphenhydramine HCl Oral Solution contains Diphenhydramine HCl 12.5 mg and is supplied in the following oral dosage forms:

NDC: 57237-317-05: 5 mL unit dose cup

NDC: 57237-317-51: 100 x 5 mL Unit-Dose Cups

PRINCIPAL DISPLAY PANEL

12.5 mg/5 mL

Case Label NDC: 57237-317-51

Lid Label NDC: 57237-317-05

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-317
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-317-51	100 in 1 BOX, UNIT-DOSE	12/15/2023
1	NDC: 57237-317-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009.50	12/15/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Lohxa (079872715)

Establishment
Name	Address	ID/FEI	Business Operations
Lohxa		079872715	pack(57237-317)

Establishment
Name	Address	ID/FEI	Business Operations
Ultrum Labs, LLC		060934179	manufacture(57237-317) , analysis(57237-317)