Diphenhydramine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine HCl

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Nighttime Sleep Aid




FULL PRESCRIBING INFORMATION

(in each tablet)

Diphenhydramine HCl 50 mg 

Sleep Aid

relieves occasional sleeplessness

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • adults & children 12 years and over: one tablet at bedtime
  • children under 12 years: ask a doctor
  • each tablet contains: calcium 86 mg
  • store at room temperature 15°-30°C (59°-86°F)

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

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

Diphenhydramine HCl

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 label Item Code (Source) NDC:0536-3772
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 1
cellulose, microcrystalline
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
BLUE 11 mm AP;023 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3772-06 50 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-07-13


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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