Figure 1 (Revatio 01)
Revatio
Product Images NDC 0069-0336
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Product Visual Gallery
This gallery contains 28 technical images submitted to the FDA as part of the official labeling for Revatio (NDC 0069-0336). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Pfizer Laboratories Div Pfizer Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Figure 2 (Revatio 02)
Figure 3 (Revatio 03)
Figure 4 (Revatio 04)
Figure 5 (Revatio 05)
Figure 6 (Revatio 06)
Chemical Structure (Revatio 07)
Figure 7 (Revatio 08)
This is a table of drug interactions with Sildenafil, where recommendations for doses adjustments are given based on the fold change and 90% confidence interval. Atorvastatin, Azithromycin, Cimetidine, Erythromycin, and Oral Contraceptives do not require dose adjustments concerning Auc and Cmax. On the other hand, Bosentan and Saquinavir do not need dose adjustment for Cmax but do have it for Auc. Finally, Ritonavir has an Auc fold change of H84, and a dose adjustment is not recommended. A note points out that the combination of bosentan and sildenafil does not improve exercise capacity.*
Figure 8 (Revatio 09)
This appears to be a list of drugs that interact with 'Acenocoumarol'. Each interaction has information on the effect on 'INR AUC', 'INR Cmax', 'BT', 'AuC', and 'Cmax'. There is also a recommendation for each interaction, which includes no dose adjustment or not recommended. One note mentions the lack of improvement in exercise capacity when sildenafil is added to bosentan therapy.*
Figure 9 (Revatio 10)
This appears to be a table showing the change from baseline (measured in meters) for each week of a study where participants were given different doses of a drug called sildenafil. The key indicates the different dosages given: 40mg TID, 80mg TID, 20mg TID, or a placebo. There is not enough information to determine the context or purpose of the study.*
Figure 10 (Revatio 11)
Figure 11 (Revatio 12)
Figure 12 (Revatio 13)
The plot displays the average change from the baseline with the corresponding standard error for each treatment at every visit up to week 12. There are also numerical values represented on the graph, showing the change from the baseline in meters. Additionally, there is information about the different dosages of Sildenafil given three times a day - 6mg, 9mg, and 20mg.*
Logo (Revatio 14)
This text is a description of the distributor of a product which is Pfizer Labs. It is a division of Pfizer Inc, located in NY, NY 10017.*
Revatio 14a
This is a description of a company called Pfizer Labs, which is a division of Pfizer Inc. located in NY, NY 10017. They distribute products, but the specific type of products is not mentioned.*
Figure A (Revatio 15)
The text describes a "syringe adaptor" along with a "bottle of REVATIO oral suspension". It also mentions a "barrel" and a "plunger". However, without additional context or information, it is unclear how these components are related or what purpose they serve.*
Figure B (Revatio 16)
Figure C (Revatio 17)
Figure D (Revatio 18)
Figure E (Revatio 19)
Figure F (Revatio 20)
Figure G (Revatio 21)
Revatio 21a
This text is a notation indicating that Pfizer Labs is the distributor of a product or products that come from a division of the Pfizer Inc. company located in New York, with zip code 10017.*
Principal Display Panel (20 mg Bottle Label)
This is a prescription drug called Revatio (sildenafil) which is distributed by Pfizer Labs. The drug comes in the form of tablets and is stored at a controlled room temperature between 68°F to 77°F with permissible temperature excursions ranging from 59°F to 86°F. The drug should only be dispensed in light containers as per USP. The dosage and use instructions can be found in the accompanying prescribing information. However, some of the text is unreliable due to errors.*
Principal Display Panel (10 mg/12.5 mL Vial Label)
Store the medication at a controlled room temperature between 68°F to 77°F. Excursions permitted to 59°F to 86°F. It is a sterile single-use injection containing 1.126 mg of sildenafil, 50.5 mg of dextrose, and 10 mg of water for injection. The medication is for intravenous use only. There are accompanying instructions for usage.*
Principal Display Panel (10 mg/12.5 mL Vial Carton)
This is a description of a medicine called "Revatio®". It is a sterile single-use injection containing 10 mg/12.5 mL (0.8 mg/ml) of sildenafil for intravenous use. The solution also contains dextrose and water for injection. The dosage and use instructions are mentioned in the accompanying prescribing information. The injection needs to be discarded if unused. The medicine is packaged in a vial with a unique product identifier (GTIN: 0300690338019) and distributed by Pfizer Labs. It needs to be stored at controlled room temperature (20°C - 25°C) with permitted excursions to 15°C - 30°C (see USP controlled room temperature). The product is manufactured in Ireland.*
Principal Display Panel (10 mg/mL Bottle Label)
This text provides instructions for storing and using a medication called Revatio (containing sildenafil) before and after reconstitution. The medication should be stored below 30°C before reconstitution, and after reconstitution, it can be stored in a refrigerator. The medication should not be frozen and any unused portion should be discarded after 60 days. Each mL of the suspension contains 10 mg of sildenafil, and the recommended dosage should be followed as per the prescribing information. The medication is meant for oral use only and is grape-flavored. The details of lot and expiration date are not available.*
Principal Display Panel (10 mg/mL Bottle Carton)
Revatio® is a sildenafil-based oral suspension, available in a grape flavor. It is meant to be used for oral purposes only, after being shaken well. The suspension needs to be reconstituted first, as directed in the packaging. The recommended dosage can be found in the prescribing information. The reconstituted suspension needs to be stored below 30°C or in refrigeration below 2°-8°, and not refrigerated again or used after 60 days. The package contains a dosing syringe and a press-and-release bottle adapter. The product is distributed by Pfizer Labs and made in Finland.*
* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.
