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

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Diphenhydramine Hydrochloride

Advance Pharmaceutical Inc.
Advance Pharmaceutical Inc.

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 50mg




FULL PRESCRIBING INFORMATION

(in each capsule)

Diphenhydramine HCl 50 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.

  • adults and children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 50 MG

ANTIHISTAMINE

NDC: 17714-021-01 – 100 COUNT

NDC: 17714-021-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:17714-021
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
BENZYL ALCOHOL
BUTYLPARABEN
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
polysorbate 80
PROPYLPARABEN
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
PINK 14 mm AP;021 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17714-021-01 100 in 1 BOTTLE
2 NDC:17714-021-10 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1989-10-05


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Be sure to consult your doctor before taking any medication!
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