DIPHENHYDRAMINE HCL- diphenhydramine hcl tablet
Rugby Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nighttime Sleep Aid

Active Ingredient

(in each tablet)

Diphenhydramine HCl 50 mg

Purpose

Sleep Aid

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

•: trouble urinating due to an enlarged prostate gland
•: glaucoma
•: 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

•: avoid alcoholic drinks
: Stop and ask a doctor if sleeplessness lasts more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
: 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.

Direction

•: adults & children 12 years and over: one tablet at bedtime
•: children under 12 years: ask a doctor

Other Information

•: each tablet contains: calcium 86 mg
•: store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredient

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 alum.lake, magnesium stearate, microcrystalline cellulose

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Rugby® Duluth, Georgia 30097

Package Label

Nighttime sleep aid

Diphenhydramine HCl 50 mg

Adult Strength

NDC 0536-3772-06

50 BLUE TABLETS

Rugby

Duluth, Georgia 30097

DIPHENHYDRAMINE HCL
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3772
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AP;023
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-3772-06	50 in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2007	05/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/13/2007	05/15/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: 09dfadd2-8a5f-4127-aa06-fe727f418b53

Set id: 66d3cb86-df2c-443f-9bdd-79995b55d0a4

Version: 4

Effective Time: 20191220

Rugby Laboratories Inc.