Atovaquone (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Atovaquone Oral Suspension, USP is a bright yellow, tutti frutti flavored, oral suspension containing 750 mg of atovaquone USP per 5 mL. It is supplied as follows:
- NDC 16714-900-01 Bottle of 210 mL with child-resistant cap.
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.
17 PATIENT COUNSELING INFORMATION
Instruct patients to:
- Ensure the prescribed dose of atovaquone oral suspension is taken as directed.
- Take their daily doses of atovaquone oral suspension with food, as food will significantly improve the absorption of the drug.
- Shake atovaquone oral suspension gently before use each time.
- Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].
Northstar Rx LLC
Memphis, TN 38141.
Glenmark Pharmaceuticals Limited
Village: Kishanpura, Baddi Nalagarh Road,
Dist. Solan, Himachal Pradesh -173205, India
Package/Label Display Panel
Atovaquone Oral Suspension, USP
750 mg/5 ml
| ATOVAQUONE |
|Labeler — Northstar Rx LLC (830546433)|
|Glenmark Pharmaceuticals Limited||676115028||MANUFACTURE (16714-900), ANALYSIS (16714-900)|
|Glenmark Pharmaceuticals Limited||650283737||API MANUFACTURE (16714-900)|
Revised: 09/2019 Northstar Rx LLC
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