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Diphenhydramine by New World Imports, Inc

Dosage form: tablet, coated
Ingredients: Diphenhydramine Hydrochloride 25mg
Labeler: New World Imports, Inc
NDC Code: 51824-048

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.

Drug Facts

 Diphenhydramine HCL 25mg


In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Temporarily relieves these symptoms associated with the common cold:

Sneezing, runny nose

Do not use with any other products containing diphenhydramine, including one applied topically

Ask a doctor before use if you have:

A breathing problem such as emphysema or chronic bronchitis


Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product:

Marked drowsiness may occur

Avoid alcoholic beverages

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

Take every 4 to 6 hours

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and older; 1 to 2 caplets

Children 6 to 12 years: 1 caplet

Children under 6: Consult a doctor

Enter section text here

diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-048
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (DIPHENHYDRAMINE) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
Magnesium Stearate 
Cellulose, Microcrystalline  
Silicon Dioxide 
Titanium Dioxide 
Product Characteristics
Colorpink (Bright Pink) Scoreno score
ShapeOVAL (Oval in Shape, sides straight, top and bottom rounded) Size11mm
FlavorImprint Code048;D
#Item CodePackage Description
1NDC:51824-048-01100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/09/201008/01/2020
Labeler - New World Imports, Inc (075372276)

Revised: 08/2017
New World Imports, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.