DIPHENHYDRAMINE HCL liquid

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:
  • 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 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 (1-800-222-1222) 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

Principal display panel

MAJOR®

NDC: 0904-6985-20

Diphenhydramine HCl
Oral Solution

Antihistamine

12.5 mg/5 mL

Institutional Dispensing only

Cherry Flavored
Alcohol Free

4 FL OZ / 118 mL

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

50844     ORG051901536
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Rev. 11/19    M-17       Re-order No. 701180

Major 44-015

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6985
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
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6985-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/27/2019
2	NDC: 0904-6985-20	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/27/2019

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(0904-6985) , PACK(0904-6985)