Diphenhydramine HCl by Rugby Laboratories Inc. / Advance Pharmaceutical Inc. Nighttime Sleep Aid

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

08ece8f0-figure-01

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3772
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code AP;023
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-3772-0650 in 1 BOTTLE; Type 0: Not a Combination Product07/13/200705/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/200705/15/2018
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.