NDC 68210-1510 Diphenhydramine Hydrochloride
Product Information
Usage Information
This product is used as Nighttime Sleep aid. For relief occasional sleeplessness
Product Characteristics
| Color(s) | BLUE (C48333) |
| Shape | OVAL (C48345) |
| Size(s) | 18 MM |
| Imprint(s) | 293 |
| Score | 1 |
Product Packages
NDC 68210-1510-1
Package Description: 1 BAG in 1 DRUM > 10000 CAPSULE, LIQUID FILLED in 1 BAG
NDC 68210-1510-4
Package Description: 1 BAG in 1 DRUM > 4000 CAPSULE, LIQUID FILLED in 1 BAG
NDC 68210-1510-6
Package Description: 1 BAG in 1 DRUM > 6000 CAPSULE, LIQUID FILLED in 1 BAG
NDC 68210-1510-8
Package Description: 1 BAG in 1 DRUM > 8000 CAPSULE, LIQUID FILLED in 1 BAG
Product Details
Diphenhydramine Hydrochloride is product labeled by Spirit Pharmaceuticals,llc. The product's dosage form is and is administered via form.
What are Diphenhydramine Hydrochloride Active Ingredients?
The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
- DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)
NDC to RxNorm Crosswalk
What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:
Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- 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)
* Please review the disclaimer below.
Patient Education
Diphenhydramine
Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
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Diphenhydramine Hydrochloride Labeling and Warnings
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
- OTHER
- ACTIVE INGREDIENTS (IN EACH LIQUICAP)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 50 MG SHIPPER LABEL
Other
Drug Facts
Active Ingredients (In Each Liquicap)
Diphenhydramine HCl 50 mg
Purpose
Nighttime Sleep aid
Uses
For relief occasional sleeplessness
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
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
* Please review the disclaimer below.