Diphenhydramine Hydrochloride Tablets, Usp 50mg

Diphenhydramine Hydrochloride Tablets, Usp 50mg
SPL v2
SPL
SPL Set ID d1f51b7b-da65-4637-8199-f7d59e6dd1c1
Route
ORAL
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: AP;023 Shape: round Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-01

Description

(in each TABLET) Diphenhydramine HCl 50 mg

Purpose

Sleep Aid


Medication Information

Purpose

Sleep Aid

Description

(in each TABLET) Diphenhydramine HCl 50 mg

Uses

 relieves occasional sleeplessness

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 tablet at bedtime
  • children under 12 years: ask a doctor
Active Ingredient

(in each TABLET)

Diphenhydramine HCl 50 mg

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C blue# 1(Al-lake), Magnesium stearate, microcrystalline cellulose.

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

Call 631-981-4600, 8:30 am to 4:30 pm ET, Monday-Friday

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 Tablet, USP 50 MG

ANTIHISTAMINE

NDC: 17714-023-50 – 50 COUNT


Structured Label Content

Uses

 relieves occasional sleeplessness

Purpose

Sleep Aid

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 tablet at bedtime
  • children under 12 years: ask a doctor
Active Ingredient

(in each TABLET)

Diphenhydramine HCl 50 mg

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C blue# 1(Al-lake), Magnesium stearate, microcrystalline cellulose.

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

Call 631-981-4600, 8:30 am to 4:30 pm ET, Monday-Friday

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 Tablet, USP 50 MG

ANTIHISTAMINE

NDC: 17714-023-50 – 50 COUNT


Advanced Ingredient Data


Raw Label Data

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