DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1510
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	293
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1510-4	1 in 1 DRUM
1		4000 in 1 BAG
2	NDC: 68210-1510-6	1 in 1 DRUM
2		6000 in 1 BAG
3	NDC: 68210-1510-8	1 in 1 DRUM
3		8000 in 1 BAG
4	NDC: 68210-1510-1	1 in 1 DRUM
4		10000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	06/01/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)