DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule
St. Mary's Medical Park Pharmacy

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 capsule)

Diphenhydramine HCL 50 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 HCL, including one applied topically.

Ask a doctor or pharmacist before use

If you have

Trouble urinating due to enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
If 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 overdose, get medical help or contact a Poison Control Center right away.

Directions:

Take every 4-6 hours
Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over	1 capsule
Children under 12 years	ask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture

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:

1-800-687-0176

diph

DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-331(NDC:66424-021)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
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 (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60760-331-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/14/2018	10/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/14/2018	10/31/2020

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Name	Address	ID/FEI	Business Operations
Establishment
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-331) , repack(60760-331)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(60760-331)

Revised: 12/2021

Document Id: d24517c9-11d3-28f5-e053-2995a90a0196

Set id: 676194cc-559d-59d8-e053-2991aa0a2a6a

Version: 3

Effective Time: 20211203

St. Mary's Medical Park Pharmacy