Diphenhydramine hydrochloride solution

Drug facts

Active ingredient [in each20 mL]

Diphenhydramine HCl, USP 50 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • 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
  • a sodium-restricted diet
  • trouble urinating due to enlarged prostate

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.(1-800-222-1222)

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • not to exceed 300 mg in 24 hours
  • mL = milliliter
Age (yr)
Dose (mL)
Adult and children 12 years and older
10 mL to 20 mL
Children under 12 years
Consult a doctor

Attention:use only enclosed dosing cup specifically designed for use with this product.

Do not use any other dosing device.


Other information

  • each 20 mL contains: sodium 56 mg
  • store between 20-25C (68-77F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or comments?

1-855-274-4122

Distributed By
Amerisource Bergen
1300 Morris Drive
Chesterbrook, PA 19087
Visit us at
www.mygnp.com

Ingredients and appearance - Product information

Diphenhydramine hydrochloride solution- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 46122-356
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 20 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Cherry ( UNII: BUC5I9595W)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Poloxamer 407 ( UNII: TUF2IVW3M2)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium chloride ( UNII: 451W47IQ8X)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color YELLOW (Colorless to Pale Yellow) Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Amerisource Bergen( 007914906)

Establishment

Name ID/FEI Business Operations
Amerisource Bergen 007914906 MANUFACTURE( 46122-356)

Package label-principal display panel 4 fl oz (118 ml bottle)

NDC 46122-356-26

GOOD
NEIGHBOR
PHARMACY ®

MAXIMUM STRENGTH
ALLERGY

Antihistamine

diphenhydramine hydrochloride
50 mg/20 mL oral solution
liquid medication

Relieves:

  • Runny nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

Dye-Free &
Alcohol Free

Cherry Flavor

4fl OZ
(118 mL)