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

Purpose

Sleep Aid

Description

(in each TABLET) Diphenhydramine HCl 50 mg


Medication Information

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.

Uses

 relieves occasional sleeplessness

Purpose

Sleep Aid

Directions
  • adults and children 12 years and over: take 1 tablet at bedtime
  • children under 12 years: ask a doctor
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.

Description

(in each TABLET) Diphenhydramine HCl 50 mg

Active Ingredient

(in each TABLET)

Diphenhydramine HCl 50 mg

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

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.

Uses

 relieves occasional sleeplessness

Purpose

Sleep Aid

Directions
  • adults and children 12 years and over: take 1 tablet at bedtime
  • children under 12 years: ask a doctor
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.

Active Ingredient

(in each TABLET)

Diphenhydramine HCl 50 mg

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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