Product Specifications
| Specification | Details |
| Manufacturer / Brand | Hikma Pharmaceuticals USA Inc. / Phenergan® |
| Manufacturer SKU / Item # | 00641608225 |
| NDC Number | 00641-6082-25 (Box) |
| Active Ingredient | Promethazine Hydrochloride (25 mg/mL) |
| Strength / Concentration | 25 mg per 1 mL |
| Volume per Unit | 1 mL |
| Container Type | Glass Single-Dose Ampule |
| Administration Route | Deep Intramuscular (IM) Injection (Preferred) / IV Infusion (Diluted) |
| Formulation | Sterile / Pyrogen-Free / Light-Sensitive |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Protect from light) |
| Packaging Configuration | 25 Ampules per Box / Carton |
| Regulatory Category | Prescription-Only (Rx) |
| HCPCS Code |
Key Features & Clinical Applications
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Multi-Indication Antiemetic & Sedative: Indicated for the prevention and control of nausea and vomiting associated with surgery, anesthesia, or motion sickness.
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Pre/Post-Operative & Obstetric Sedation: Used as a sedative to relieve apprehension, induce light sleep, and serve as an adjunct to analgesics during perioperative care or labor.
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Severe Allergic Reaction Relief: Treats uncomplicated allergic conditions and serves as an adjunct to epinephrine for severe allergic or anaphylactic reactions.
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Convenient Single-Dose Packaging: 1 mL individual glass ampules ensure proper single-patient unit dosing and minimize waste.
⚠️ BOXED WARNING — SEVERE TISSUE INJURY & GANGRENE: The preferred route of administration is deep intramuscular (IM) injection. Subcutaneous (SC) injection is strictly prohibited. Extreme care must be exercised if given intravenously; perivascular extravasation or accidental intra-arterial injection can cause severe chemical irritation, tissue necrosis, thrombosis, and gangrene leading to amputation.
⚠️ BOXED WARNING — PEDIATRIC RESPIRATORY DEPRESSION: Contraindicated in pediatric patients under 2 years of age due to the risk of severe, potentially fatal respiratory depression. In children 2 years and older, administer the lowest effective dose.
