Diphenhydramine hcl capsule

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

Ingredients and appearance - Product information

Diphenhydramine hcl capsule- Diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63187-866
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
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 Size 14 mm
Shape CAPSULE Score 1
Imprint Code PH013

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

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

Package label.principal display panel