DIPHENHYDRAMINE HYDROCHLORIDE liquid

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT (in each 5 mL)

Diphenhydramine HCl 12.5mg

PURPOSE

Antihistamine

USES

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

WARNINGS

Do not use

to make a child sleepy

with any other product containing diphenhydramine, even one used on skin

this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if your 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 sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfin

When using this product

marked drowsiness may occur

sedatives and tranquilizers may increase drowsiness

excitability may occur, especially in children

avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Keep our of reach of children

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

DIRECTIONS

Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

OTHER INFORMATION

each 5 mL contains: 16mg of sodium

store at 20°-25°C (68°-77°F)

tamper evident: DO NOT use if foil on cup is missing or torn

Alcohol Free, Dye Free, Sugar Free

NDC: 81033-003-05 (12.5mg) unit dose cup

NDC: 81033-003-10 (25 mg) unit dose cup

INACTIVE INGREDIENTS

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

QUESTIONS or COMMENTS?

Call 1-833-537-4679

HOW SUPPLIED

NDC: 81033-003-05 (12.5mg) unit dose cup

NDC: 81033-003-10 (25 mg) unit dose cup

PRINCIPAL DISPLAY PANEL

[ Barcode]

NDC: 81033-003-05

Diphenhydramine

HCl Oral Solution

Delivers 12.5mg / 5 mL

12.5mg / 5 mL

Store at 68° - 77° F

[ Lot # Exp Date]

PKG by Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

[Barcode]

NDC: 81033-003-10

Diphenhydramine

HCl Oral Solution

Delivers 25mg / 10 mL

12.5mg / 5 mL

Store at 68° - 77° F

[Lot #] PKG by

[Exp Date] Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2.5 mg  in 1 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-003-52	8 in 1 CASE	09/16/2021
1	NDC: 81033-003-50	50 in 1 CARTON
1	NDC: 81033-003-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-003-41	8 in 1 CASE	09/16/2021
2	NDC: 81033-003-40	40 in 1 CARTON
2	NDC: 81033-003-10	10 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 final	part341	09/16/2021

Labeler - Kesin Pharma Corporation (117447816)