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Diphenhydramine HCl by Rugby Laboratories Inc.

Medically reviewed on Dec 11, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3772

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3772
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAP;023
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3772-0650 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2007
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3772)

 
Rugby Laboratories Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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