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

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DIPHENHYDRAMINE HYDROCHLORIDE

SPIRIT PHARMACEUTICALS,LLC

Diphenhydramine Hydrochloride Soft Gelatin Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each LiquiCap)

Diphenhydramine HCl 50 mg

Purpose

Nighttime Sleep aid

DIPHENHYDRAMINE HYDROCHLORIDE Uses

For relief occasional sleeplessness

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing Diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • Glaucoma
  • trouble urinating due to enlarged postage 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 avoid alcoholic drinks

Stop use and ask 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.

In case of overdose,get medical help or contact a poison control center right away.

Direction

adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor

Inactive ingredients

PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water

PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label

Diphenhydramine Hydrochloride Soft Gelatin Capsules

Each soft gelatin capsule contains:
Diphenhydramine Hydrochloride USP 50 mg

LOT NO :

MFG DATE :

EXP. DATE :

NDC NO : 68210-1510-4

QUANTITY : 1000 × 4 Capsules

GROSS WT. :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
Marksans Pharma Ltd
VERNA, GOA-403722,
INDIA.
CODE : GO/DRUGS/515

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

OLIL058

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-1510
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
polyethylene glycol 400
propylene glycol
GELATIN
sorbitol
water
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
BLUE 18 mm 293 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4000 in 1 BAG
2 6000 in 1 BAG
3 8000 in 1 BAG
4 10000 in 1 BAG
5 NDC:68210-1510-1 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2010-06-01


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Be sure to consult your doctor before taking any medication!
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