DIPHENHYDRAMINE HCL capsule

Diphenhydramine HCL by

Drug Labeling and Warnings

Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-866(NDC:66424-021)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 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	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-866-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017
2	NDC: 63187-866-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017
3	NDC: 63187-866-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/27/2010

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-866)