DIPHENHYDRAMINE HCL liquid

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc., SLV PHARMACEUTICALS LLC. 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

Bubble Gum Flavor, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sucrose.

Questions or comments?

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc,
Fairfield, NJ 07004
Manufactured in U.S.A

PRINCIPAL DISPLAY PANEL

4 FL OZ (118 mL)

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0125
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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0125-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2019
2	NDC: 71399-0125-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/25/2019

Labeler - Akron Pharma Inc. (067878881)

Registrant - Akron Pharma Inc. (067878881)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-0125)