Diphenhydramine Hydrochloride Capsules, Usp 25mg

Diphenhydramine Hydrochloride Capsules, Usp 25mg
SPL v6
SPL
SPL Set ID 4e66c626-607f-4558-ab2e-2dd9a25f7be4
Route
ORAL
Published
Effective Date 2012-08-31
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 1989-09-12

Description

(in each capsule) Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

(in each capsule) Diphenhydramine HCl 25 mg

Uses

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

  • runny nose
  • itchy nose or throat
  • sneezing
  • 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 tranquilizers

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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 and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor
Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Inactive Ingredients

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

Questions Or Comments

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 17714-020-01 – 100 COUNT

NDC: 17714-020-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)


Structured Label Content

Uses

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

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

Antihistamine

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 tranquilizers

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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 and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor
Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Inactive Ingredients

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

Questions Or Comments (Questions or Comments)

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 17714-020-01 – 100 COUNT

NDC: 17714-020-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)