| Product Name: | Diphenhydramine hydrochloride injection USP |
| Brand Name: | Generics |
| Strength: | 10mg/ml |
| Dosage Form: | Sterile, pyrogen-free |
| Packing: | 10ml vial, 1ml vial |
| Route of Administration: | For I.M. / I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihistamines |
| Indication: | Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness. |
| Storage: | Store at 20 to 25oC (68o to 77oF)see usp controlled room temperature, protect from light, keep from freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Diphenhydramine hydrochloride injection USP 10mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
- Diphenhydramine hydrochloride injection USP 10mg/ml
Each ml contains:
Diphenhydramine hydrochloride USP………….10mg
water for Injection…………………………..q.s.
THERAPEUTIC INDICATIONS:
Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness.
CAUTION & WARNING:
CAUTION: Crystals may be rarely formed when preserved in a cold place. In such cases dissolve the crystals by warming before use.WARNING: Not to be sold by retail without the prescription of a registered medical practitionerThis drug is to be administered under expert medical supervision only.
STORAGE & DOSAGE:
Storage: Store at 20 to 25oC (68o to 77oF)see usp controlled room temperature, protect from light, and keep from freezing.
Dosage: As directed by the Physician.