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 Major Pharmaceuticals. 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

Active ingredient per 10 mL (1 Unit Dose)

Diphenhydramine HCl 25 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 istaking 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 

For the 5 mL Unit-Dose: 

 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)

Directions

For the 10 mL Unit-Dose:

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 6 years of age	Do not use
Children 6 to under 12 years of age	10 mL (25 mg)
Adults and children 12 years of age and over	10 mL (25 mg) to 20 mL (50 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 INGREDIENT

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

QUESTIONS

Questions or comments? (855) 879-4368

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Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

(800) 616-2471

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC: 0904-7323-41

Each 5 mL Contains:

Diphenhydramine HCL Oral Solution 

12.5 mg/5 mL

Antihistamine

Delivers 5 mL See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free  Alcohol Free

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC: 0904-7324-66

Each 10 mL Contains:

Diphenhydramine HCL Oral Solution 

25 mg/10 mL

Antihistamine

Delivers 10 mL See insert

For Institutional Use Only

Cherry Flavor 

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Sugar Free  Alcohol Free

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7323
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)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 0904-7323-70	100 in 1 BOX, UNIT-DOSE	01/22/2024	06/30/2026
1	NDC: 0904-7323-41	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	M012	01/22/2024	06/30/2026

DIPHENHYDRAMINE HCL ORAL SOLUTION 
diphenhydramine hcl oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7324
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 10 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)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 0904-7324-72	100 in 1 BOX, UNIT-DOSE	01/22/2024	07/31/2026
1	NDC: 0904-7324-66	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 Drug	M012	01/22/2024	07/31/2026

Labeler - Major Pharmaceuticals (191427277)