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DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form
CAPSULE, LIQUID FILLED
Labeler
SPIRIT PHARMACEUTICALS,LLC
Label updated
2010-07-26
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredients (in each LiquiCap)

Diphenhydramine HCl 50 mg

Purpose

Nighttime Sleep aid

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

Label information

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

Label information

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.

Label information

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

Label information

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

[Image in the official label — see DailyMed source]

DailyMed Set ID: 01ba06dd-fe81-465b-ad53-cdccde45f8e2 · Version 2
NDC: 68210-1510