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 50 mg capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

DIPHENHYDRAMINE HYDROCHLORIDE Uses

  • for the relief of occasional sleeplessness

Warnings

  • do not give to children under 12 years of age
  • do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product avoid alcoholic drinks.

Stop use and ask a doctor if

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

Directions

  • adults and children 12 years of age and over: 1 softgel (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) and avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C blue #1, 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, 50 mg

Quantity : 12000 Capsules
NDC. No : 53345-005-01

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

PRINCIPAL DISPLAY PANEL - Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg

Quantity : 80 Bottles
NDC. No : 53345-005-02

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:53345-005
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
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
blue 13 mm PC5 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12000 in 1 BAG
2 32 in 1 BOTTLE, PLASTIC
3 NDC:53345-005-02 80 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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