Diphenhydramine HCl Oral Solution

Diphenhydramine HCl Oral Solution

Drug Labeling and Warnings

Drug Details

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DYE-FREE ADULT ALLERGY LIQUID MEDICATION - diphenhydramine hydrochloride solution 
Aurohealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCl Oral Solution

Drug Facts

Active ingredient [in each 20 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 you have

  • 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 are taking 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 (1-800-222-1222) right away.

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 20-25°C (68-77°F). 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:

AUROHEALTH LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

NDC: 58602-517-24
Primary Health
MAXIMUM STRENGTH
Dye-Free Adult
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE
DIPHENHYDRAMINE
HYDROCHLORIDE
50 mg/20 mL
ORAL SOLUTION
 

Relieves:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat

Alcohol-Free

Dye-Free
Cherry Flavor
 
 

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Carton)

NDC: 58602-517-24
Primary Health
MAXIMUM STRENGTH
Dye-Free Adult
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE
DIPHENHYDRAMINE
HYDROCHLORIDE
50 mg/20 mL
ORAL SOLUTION
 

Relieves:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat

Alcohol-Free

Dye-Free
Cherry Flavor
 
 

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Carton)

DYE-FREE ADULT ALLERGY LIQUID MEDICATION 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-517
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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 (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (Colorless to Pale Yellow) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-517-241 in 1 CARTON09/24/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/24/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-517)

Revised: 9/2018
 
Aurohealth LLC


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