BENALDRYL - diphenhydramine hcl  tablet 
AJES PHARMACEUTICALS,LLC

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.

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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

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copy of label

BENALDRYL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorpink (pink) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code C22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42787-104-121 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/FEIBusiness Operations
AJES PHARMACEUTICALS,LLC159945393manufacture(42787-104) , repack(42787-104) , relabel(42787-104)

Revised: 5/2014
Document Id: 6854488c-af16-4d30-9a24-bcf3aafac41e
Set id: a5df4f25-fa80-49ac-922d-60a6d1abe8d5
Version: 1
Effective Time: 20140525
 
AJES PHARMACEUTICALS,LLC