Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 68210-1510-1, 68210-1510-4, 68210-1510-6, 68210-1510-8 - Packager: SPIRIT PHARMACEUTICALS,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each LiquiCap)
- Purpose
- Uses
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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
- Direction
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label
Diphenhydramine Hydrochloride Soft Gelatin Capsules
Each soft gelatin capsule contains:
Diphenhydramine Hydrochloride USP 50 mgLOT NO :
MFG DATE :
EXP. DATE :
NDC NO : 68210-1510-4
QUANTITY : 1000 × 4 Capsules
GROSS WT. :
WARNING:
KEEP OUT OF REACH OF CHILDRENSTORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS 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/515MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
OLIL058
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule, liquid filledProduct 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)