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Diphenhydramine by New World Imports, Inc

Medically reviewed on August 8, 2017

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

Antihistamine

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

Glaucoma

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

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DIPHENHYDRAMINE  
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
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
HYDROXYMETHYL CELLULOSE 
Lactose 
Magnesium Stearate 
Cellulose, Microcrystalline  
POLYETHYLENE GLYCOLS 
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
Contains    
Packaging
#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)

 
New World Imports, Inc

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Further information

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

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