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Diphenhydramine by H.J. Harkins Company, Inc.

Medically reviewed on Apr 18, 2018

Dosage form: capsule
Ingredients: Diphenhydramine Hydrochloride 50mg
Labeler: H.J. Harkins Company, Inc.
NDC Code: 52959-053

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

Purpose

Antihistamine

Use

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.

Warning

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.

Directions

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.

Questions?

Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Label


DIPHENHYDRAMINE  
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-053(NDC:0904-5307)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride50 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin 
Lactose 
Croscarmellose Sodium 
Silicon Dioxide 
FD&C RED NO. 40 
Magnesium Stearate 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize4mm
FlavorImprint Codecpc;836
Contains    
Packaging
#Item CodePackage Description
1NDC:52959-053-0606 CAPSULE (CAPSULE) in 1 BOTTLE
2NDC:52959-053-1212 CAPSULE (CAPSULE) in 1 BOTTLE
3NDC:52959-053-1515 CAPSULE (CAPSULE) in 1 BOTTLE
4NDC:52959-053-2020 CAPSULE (CAPSULE) in 1 BOTTLE
5NDC:52959-053-1010 CAPSULE (CAPSULE) in 1 BOTTLE
6NDC:52959-053-3030 CAPSULE (CAPSULE) in 1 BOTTLE
7NDC:52959-053-5252 CAPSULE (CAPSULE) 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)
Establishment
NameAddressID/FEIOperations
H.J. Harkins Company, Inc.147681894repack, relabel

 
H.J. Harkins Company, 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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