DIPHENHYDRAMINE HYDROCHLORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

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DIPHENHYDRAMINE HYDROCHLORIDE

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

DIPHENHYDRAMINE HYDROCHLORIDE Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • do not use with NyQuil

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only one dose per day (24 hours) -  see Overdose warning

adults & children

12 yrs & over

                     One dose = TWO 25 mg softgels (50 mg)

                     at bedtime if needed or as directed by a doctor

DIPHENHYDRAMINE HYDROCHLORIDE Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg

Quantity : 20000 Capsules
NDC. No : 53345-002-02

IMPORTANT: 

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53345-002
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
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
purple 15 mm PC11 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20000 in 1 BAG
2 NDC:53345-002-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2013-04-15


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Be sure to consult your doctor before taking any medication!
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