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Diphenhydramine Hydrochloride by Proficient Rx LP

Medically reviewed on August 1, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Proficient Rx LP
NDC Code: 63187-771

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 25 mg

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.

Warnings:  Do not use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

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

When using this product

• marked drowsiness may occur

• 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

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 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.

Children under 6 years of age: do not use

**12.5mg dosage strength is not available in this package.  Do not attempt to break capsule

Other information

Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature].  Protect from excessive moisture.

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI  48150 USA

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Re-Order No. 301574

PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HCL CAPSULES 25MG
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-771(NDC:0904-5306)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE, UNSPECIFIED FORM 
STARCH, CORN 
GELATIN, UNSPECIFIED 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
D&C RED NO. 28 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize4mm
FlavorImprint Codecpc;835
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-771-2020 CAPSULE in 1 BOTTLE
2NDC:63187-771-3030 CAPSULE in 1 BOTTLE
3NDC:63187-771-6060 CAPSULE in 1 BOTTLE
4NDC:63187-771-9090 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2009
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-771)

 
Proficient Rx LP

← See all Diphenhydramine Hydrochloride brands

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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