DIPHENHYDRAMINE HCL- diphenhydramine hcl solution 
Preferred Pharmaceuticals Inc.

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Major 44-015-DSP

Active ingredient (in each teaspoonful (5 mL))

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
o
runny nose
o
sneezing
o
itchy, watery eyes
o
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 you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
marked drowsiness may occur
use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in 24 hours
mL = milliliter; FL OZ = fluid ounce
find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor

Age

Dose

adults and children 12 years and over

2 - 4 teaspoonsful (25 mg to 50 mg)

children 6 to 11 years

1 - 2 teaspoonsful (12.5 mg to 25 mg)

children 2 to 5 years

do not use unless directed by a doctor

children under 2 years

do not use

Other information

each teaspoonful (5 mL) contains: sodium 5 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions or comments?

(800) 616-2471

Relabeled By: Preferred Pharmaceuticals Inc.

Principal display panel

MAJOR®

NDC 68788-8274-1

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl
Oral Solution

Antihistamine

12.5 mg/5 mL

Institutional Dispensing only

Cherry Flavored
Alcohol Free

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844     REV1019A01521
Distributed by: MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Rev. 03/21    M-17      

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl Oral Solution 125mg/5mL
DIPHENHYDRAMINE HCL 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8274(NDC:0904-6985)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-8274-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug34110/14/2022
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8274)

Revised: 4/2024
Document Id: a2bbfd29-c52c-4c5c-99c2-5435df35dbc4
Set id: d3f769d7-3cbb-4469-bff8-2015619ee115
Version: 3
Effective Time: 20240410
 
Preferred Pharmaceuticals Inc.