Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

PHARBEDRYL  - diphenhydramine hcl capsule 
A-S Medication Solutions

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 banded capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:                    -Sneezing                    -Nasal congestion                    -Runny nose                    -Itchy, watery eyes

Warnings:

Do not use

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

Ask a doctor or pharmacist before use

If you haveTrouble urinating due to an enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucoma

Ask a doctor or pharmacist before use of you are

taking sedatives or tranquilizers

When using this product

• Avoid alcoholic drinks
• Marked drowsiness may occur
• Excitability may occur, especially in children
• Alcohol, sedatives and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions:

Take every 4-6 hoursDo not exceed 6 doses in 24 hours.Adults and children 12 years of age or over25 mg to 50 mg (1 to 2 capsules)                                     Children 6 to under 12 years of age12.5 mg** to 25 mg (1 capsule)Children under 6 yearsask a doctor**12.5 mg dosage strength is not available in this package.Do not attempt to break capsule.

Other information:

• Tamper Evident: Do not use if safety seal under cap is broken or missing
  
• Store at controlled room temperature 15°-30°C (59°-86°F) 
• Protect from moisture
• Use by expiration date on package

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions? Adverse drug event call: (866)562-2756

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HOW SUPPLIED

Product: 50090-1640

Diphenhydramine HCl

PHARBEDRYL  
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-1640(NDC: 16103-348)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink (PINK (clear) , WHITE (clear) , RED (band) )	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH014
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-1640-1	28 in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2015	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/11/2006	06/30/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-1640) , REPACK(50090-1640)

Revised: 2/2020

Document Id: a31f22cf-cdef-4a84-a56e-4addab9cf858

34390-5

Set id: 01540ac5-d630-4984-af93-eb03a191659b

Version: 7

Effective Time: 20200214

 

A-S Medication Solutions