DIPHENHYDRAMINE HCL- diphenhydramine hcl solution 
Major Pharmaceuticals

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Major 44-015-DSP

Active ingredient (in each teaspoonful (5 mL))

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • 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

AgeDose
adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
children 2 to 5 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use

Other information

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

MAJOR®

NDC 0904-6985-16

Diphenhydramine HCl
Oral Solution

Antihistamine

12.5 mg/5 mL

Cherry Flavored

Ages 6 Years and Over

Institutional Dispensing only

16 FL OZ (473 mL)

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

50844    REV0523B01521
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com

Major 44-015

Major 44-015

DIPHENHYDRAMINE HCL 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6985-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/2019
2NDC:0904-6985-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/27/2019
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(0904-6985) , pack(0904-6985)

Revised: 8/2023
Document Id: 5e2bea25-9aad-45e0-b506-6d999247a566
Set id: 93753885-6add-462c-9df8-b0a1b9ce36c9
Version: 10
Effective Time: 20230829
 
Major Pharmaceuticals