Skip to Content

← See all Diphenhydramine Hydrochloride brands

Diphenhydramine Hydrochloride by Physicians Total Care, Inc.

Medically reviewed on Jun 5, 2018

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5622

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.

Active ingredient (in each 5 mL teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
  • sneezing
  • runny nose

Warnings

Do not use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful 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 right away.

Directions
  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours

children under 4

years of age
do not use

children 4 to under 6

years of age
do not use unless directed by a doctor

children 6 to under

12 years of age

1 to 2 teaspoonfuls

(12.5 mg to 25 mg)

adults and children

12 years of age

and over

2 to 4 teaspoonfuls

(25 mg to 50 mg)

Other information
  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions or comments?

1-800-719-9260

Principal Display Panel

Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0


Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5622(NDC:24385-379)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-5622-01 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/2006
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

← See all Diphenhydramine Hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide