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DIPHENHYDRAMINE HYDROCHLORIDE by SPIRIT PHARMACEUTICALS,LLC

Medically reviewed on Jul 26, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-1510

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Diphenhydramine Hydrochloride Soft Gelatin Capsules

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

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1510
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
SORBITOL 
WATER 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize18mm
FlavorImprint Code293
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-1510-41 BAG (BAG) in 1 DRUM
14000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
2NDC:68210-1510-61 BAG (BAG) in 1 DRUM
26000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
3NDC:68210-1510-81 BAG (BAG) in 1 DRUM
38000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
4NDC:68210-1510-11 BAG (BAG) in 1 DRUM
410000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/01/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

 
SPIRIT PHARMACEUTICALS,LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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