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Diphenhydramine Hydrochloride by Physicians Total Care, Inc.

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 12.5mg in 5mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-1227

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.

Hydramine Liquid 0182-6168-40

Drug Facts

Active ingredient (in each teaspoon (5 mL))

Diphenhydramine HCl USP 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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
  • alcohol, 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over2 to 4 teaspoons (25 mg to 50 mg)
children 6 to under 12 yearsask a doctor
children 4 to 5 yearsdo not use unless directed by a doctor
children under 4 yearsdo not use

Other information
  • each teaspoon (5 mL) contains: sodium 5 mg
  • store between 20°-25°C (68°-77°F). Protect from light.

Inactive ingredients

artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

PRINCIPAL DISPLAY PANEL


NDC 54868-1227-0

TAMPER-EVIDENT


Diphenhydramine HCl USP
12.5 mg per 5 mL)

ONE PINT (473 mL)

ANTIHISTAMINE

ALCOHOL-FREE
SUGAR-FREE
CHERRY-FLAVORED

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

NOT FOR HOUSEHOLDS
WITH YOUNG CHILDREN


DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1227(NDC:0182-6168)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
D&C Red no. 33 
FD&C Red no. 40 
glycerin 
polysorbate 20 
water 
sodium benzoate 
SACCHARIN SODIUM DIHYDRATE 
sodium citrate 
sorbitol 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-1227-0473 mL in 1 BOTTLE, PLASTIC
2NDC:54868-1227-2118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/22/2002
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Medically reviewed on Jun 5, 2018

Further information

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

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