Market Place
NDC Code(s) : 75854-602-28, 75854-602-02, 75854-602-03
Packager : Avion Pharmaceuticals
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
| Balcoltralevonorgestrel and ethinyl estradiol KIT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| LABELER - Avion Pharmaceuticals(040348516) |
| REGISTRANT - Avion Pharmaceuticals(040348516) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Novast Laboratories, Ltd. | 527695995 | analysis(75854-602), label(75854-602), manufacture(75854-602), pack(75854-602) | |
PRINCIPAL DISPLAY PANEL
Blister Pack,
28 tablets.
NDC 75854-602-28
28-day regimen
Balcoltra®(levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) 0.1mg/0.02mg and 36.5mg
This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Rx Only
The inactive ingredients present in orange active tablet are FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized starch.
Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate, citric acid, glycine, water, maltodextrin , silica, microcrystalline cellulose NF, magnesium stearate NF, croscarmellose sodium NF, colloidal silicon dioxide NF, hypromellose type 2910, titanium dioxide, polyethylene glycol 400, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake and FD&C Blue #1 Aluminum Lake.
1 Blister Pack, 28 tablets
Balcoltra® (Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.
NDC 75854-602-28
28-day regimen
PRINCIPAL DISPLAY PANEL
1 Blister Pack,
28 tablets
NDC 75854-602-28
28-day regimen
Balcoltra ® Levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets) 0.1mg/0.02mg and 36.5mg.
IMPORTANT: Note to Dispensing Pharmacist: Each compact dispenser contains a combination Patient Information and Instructions For Use Insert with Day Label Stickers. This should be included with each package dispensed to the patient.
Each active orange tablet (21) contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
Each inactive blue tablet (7) contains ferrous bisglycinate 36.5 mg.
Contains color additives including FD&C Yellow No. 5 (tartrazine).
Usual Dosage: One orange tablet daily for 21 consecutive days followed by one blue placebo tablet for 7 consecutive days according to prescribed schedule.
See enclosed prescribing information.
Store at 20° to 25°C (68° to 77°F); Excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature.]Protect from light.
Keep out of the reach of children.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children.
In case of accidental overdose, call a doctor or poison control center immediately.
Avion
Pharmaceuticals
Manufactured for:
Avion Pharmaceuticals, LLC., Alpharetta, GA 30005
1-888-61-AVION
Manufactured by:
Novast Laboratories, Ltd., Nantong, China 226009
Rx Only
Iss. 04/2022 Rev C
C0154
