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BENALDRYL by AJES PHARMACEUTICALS,LLC

Medically reviewed on May 25, 2018

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 250mg
Labeler: AJES PHARMACEUTICALS,LLC
NDC Code: 42787-104

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

Active Ingredient (in each tablet)

Diphenhydramine HCI USP 25 mg

Purpose

Antihistamine

Keep out of the reach of children

In case of accidental overdose,

seek professional assistance or contact a Poison Control Center

Uses

-temporarily relieves these symptoms due to hay fever or upper

respiratory allergies: runny nose - sneezing - itchy, watery eyes

-itching of the nose and throat - temporarily relieves these

symptoms due to the common cold: runny nose - sneezing

Warnings

Do Not Use - to make a child sleepy - with any other product

containing diphenhydramine, even one used on skin

Directions - take every 4 to 6 hours

-do not take more than 6 doses in 24 hours

adults and children 12 years of age or older - 1 to 2 tablets

children 6 years to under 12 years of age - 1 tablet

children under 6 years of age  -  do not use this product in children under 6 years of age

Enter section text here

BENALDRYL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorpink (pink) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeC22
Contains    
Packaging
#Item CodePackage Description
1NDC:42787-104-121 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
125000 mg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2012
Labeler - AJES PHARMACEUTICALS,LLC (159945393)
Establishment
NameAddressID/FEIOperations
AJES PHARMACEUTICALS,LLC159945393manufacture(42787-104), repack(42787-104), relabel(42787-104)

 
AJES PHARMACEUTICALS,LLC

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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.

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