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Diphenhist

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Diphenhist




FULL PRESCRIBING INFORMATION

(in each captab)

Diphenhydramine HCl 25 mg

Antihistamine

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

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.

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

  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
    adults and children 12 years and over 1 to 2 captabs
    children 6 to under 12 years 1 captab
    children under 6 years do not use
  • each captab contains: calcium 45 mg
  • store at room temperature
  • protect from moisture

croscarmellose sodium, D&C red # 27, dicalcium phosphate,  magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

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

Diphenhist

Diphenhist

Antihistamine

Diphenhydramine HCl 25 mg

NDC 0536-3597-01

100 CAPTABS

Rugby

Duluth, Georgia 30097

Diphenhist

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3597
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 27
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
cellulose, microcrystalline
titanium dioxide
HYPROMELLOSES
polyethylene glycol 400

Product Characteristics

Color Size Imprint Code Shape
PINK 11 mm AP;135 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3597-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-09-26


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Be sure to consult your doctor before taking any medication!
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