Diphenhydramine 25mg

Diphenhydramine 25mg
SPL v2
SPL
SPL Set ID 88f1ac7b-31a1-0636-e053-2a95a90a5001
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Benzyl Alcohol Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: AP;020 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-01-01

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Warnings

​Do not use​ with any other product containing diphenhydramine, even one used on skin

​Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

​When using this product

  • ​you may get very drowsy
  • 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

​If pregnant or breast-feeding​, ask a health professional before use.

Directions
  • adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours
  • ​children under 12 years: ask a doctor
Other Information
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
  • This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
Inactive Ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments?

call ​888-374-2791, 8:30 am - 4:30 pm ET, Monday - Friday

​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

Keep Out of the Reach of Children.

In case of overdose, get medical help or contact a Poison Control Venter right away.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

Package Label.principal Display Panel


Structured Label Content

Uses (USES)

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

​Do not use​ with any other product containing diphenhydramine, even one used on skin

​Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

​When using this product

  • ​you may get very drowsy
  • 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

​If pregnant or breast-feeding​, ask a health professional before use.

Directions (DIRECTIONS)
  • adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours
  • ​children under 12 years: ask a doctor
Other Information (OTHER INFORMATION)
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
  • This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
Inactive Ingredients (INACTIVE INGREDIENTS)

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call ​888-374-2791, 8:30 am - 4:30 pm ET, Monday - Friday

​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

Keep Out of the Reach of Children. (KEEP OUT OF THE REACH OF CHILDREN.)

In case of overdose, get medical help or contact a Poison Control Venter right away.

Active Ingredient (in Each Capsule) (ACTIVE INGREDIENT (IN EACH CAPSULE))

Diphenhydramine HCl 25 mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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