DIPHENHYDRAMINE  - diphenhydramine hydrochloride capsule 
H.J. Harkins Company, Inc.

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.


Diphenhydramine Hydrochloride Capsules

Active ingredient

Diphenhydramine Hydrochloride 50mg




Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.


Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharamcist before use if you are

taking tranquilizers or sedatives.

When using this product

you may get drowsy; 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. Do not use any other products containing diphenhydramine.

Pregnancy/breast-feeding warning

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor.

Other information

Store at controlled room temperature 59-86 degrees F.

Inactive ingredients

Lactose, starch, gelatin with bisulfites and artificial colors.


Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433



diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-053(NDC:0904-5307)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Lactose (UNII: J2B2A4N98G)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorpinkScoreno score
FlavorImprint Code cpc;836
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-053-0606 in 1 BOTTLE
2NDC:52959-053-1212 in 1 BOTTLE
3NDC:52959-053-1515 in 1 BOTTLE
4NDC:52959-053-2020 in 1 BOTTLE
5NDC:52959-053-1010 in 1 BOTTLE
6NDC:52959-053-3030 in 1 BOTTLE
7NDC:52959-053-5252 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/17/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc.147681894repack, relabel

Revised: 4/2012
Document Id: dd6764ad-1dcd-457a-a31a-5fb041c83a7f
Set id: ea0c7005-3122-4ff4-8bc1-dda8116803c1
Version: 4
Effective Time: 20120418
H.J. Harkins Company, Inc.