FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Himprit Pharmachem Pvt Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep aid
Use
relief of occasional sleeplessness
Directions
| adults and children 12 years and over | take 2 caplets at bedtime if needed or as directed by a doctor |
| children under 12 years | do not use |
Other Information
- each caplet contains: calcium 20 mg
- store between 20-25°C (68-77°F)
- do not use if carton is opened or blister unit is broken
- see side panel for lot number and expiration date
Inactive Ingredients
carnauba wax, cellulose, croscarmellose sodium dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide
Principal Display Panel - 25 Mg Label
DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE
Each Film coated Tablet Contains:
DIPHENHYDRAMINE HCL 25 MG
| Lot No | : | Jar No. | : | ||
| MFG. DATE | : | Quantity | : 100,000 Tablets | ||
| Exp. Date | : | NDC. No | : 65437-037-10 |
WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER
MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803
MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
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