DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid 
Kesin Pharma Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCl 2.5mg/mL Unit Dose Cups, 12.5mg/5 mL, 25mg/10mL

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]

DPH 5ml_UDC_final2.jpg

DPH 10ml_UDC_final2.jpg

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRY (Mixed Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81033-003-528 in 1 CASE09/16/2021
1NDC:81033-003-5050 in 1 CARTON
1NDC:81033-003-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:81033-003-418 in 1 CASE09/16/2021
2NDC:81033-003-4040 in 1 CARTON
2NDC:81033-003-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/16/2021
Labeler - Kesin Pharma Corporation (117447816)

Revised: 1/2023
Document Id: 2434b630-ca13-42c9-8b41-37ed0868e4dd
Set id: c4ed2f1f-20e8-7d01-e053-2a95a90ae1d5
Version: 2
Effective Time: 20230116
 
Kesin Pharma Corporation