Approved Labeling

Medication Guide, Patient Information Leaflet, Prescribing Information, Instructions for Use

Product	NDC number (s)	Medication Guide Patient Information Leaflet Instructions for Use	Prescribing Information
Acyclovir Tablets, USP 400 mg; 800 mg	69452-290-20 69452-290-30 69452-291-20 69452-291-30	N/A	Prescribing Information
Amantadine HCl Capsules, USP 100 mg	69452-142-20 69452-142-30	N/A	Prescribing Information
Aripiprazole Orally Disintegrating Tablets, USP 10mg; 15mg	69452-338-13 69452-339-13	Medication guide	Prescribing Information
Atovaquone Suspension, USP 750 mg/5 mL	69452-252-87	N/A	Prescribing Information
Azithromycin Tablets, USP 600 mg	69452-173-13	N/A	Prescribing Information
Azithromycin Tablets, USP 250 mg; 500 mg	69452-171-04 69452-171-13 69452-171-73 69452-172-13 69452-172-72 69452-172-74	Patient Information Leaflet	Prescribing Information
Benzonatate Capsules, USP 100 mg; 200 mg	69452-143-20 69452-143-30 69452-144-20 69452-144-30	N/A	Prescribing Information
Calcitriol Capsules 0.25 mcg; 0.5 mcg	69452-207-13 69452-207-20	N/A	Prescribing Information
Carbamazepine Tablets, USP 200mg	69452-312-20 69452-312-32	Medication guide	Prescribing Information
Cevimeline Hydrochloride Capsules 30 mg	69452-316-20	N/A	Prescribing Information
Cimetidine Tablets, USP 200 mg; 300 mg; 400 mg; 800 mg	69452-323-20 69452-323-30 69452-324-20 69452-324-30 69452-325-20 69452-325-30 69452-326-20 69452-326-30	N/A	Prescribing Information
Clobazam Oral Suspension 2.5mg/mL	69452-116-45	Medication guide	Prescribing Information
Colesevelam Hydrochloride Tablets, 625 mg	69452-158-25	N/A	Prescribing Information
Deferasirox Tablets for Oral Suspension 125mg; 250mg; 500mg	69452-159-13 69452-160-13 69452-161-13	Medication guide	Prescribing Information
Divalproex Sodium Tablet, Delayed-Release 125mg; 250mg, 500mg	69452-433-13 69452-433-20 69452-433-30 69452-434-13 69452-434-20 69452-434-30 69452-435-13 69452-435-20 69452-435-30	Medication guide
Desloratadine Tablets, USP 5 mg	69452-363-20 69452-363-30	Patient Information Leaflet	Prescribing Information
Dexamethasone Tablets, USP 4 mg; 6 mg	69452-277-20 69452-278-20	N/A	Prescribing Information
Dexamethasone Tablets, USP 2 mg	69452-276-20	N/A	Prescribing Information
Dicyclomine Hydrochloride Tablets, USP 20 mg	69452-311-20 69452-311-32	N/A	Prescribing Information
Divalproex Sodium Delayed-Release Tablets, USP 125 mg; 250 mg; 500 mg	69452-433-13 69452-433-20 69452-433-30 69452-434-13 69452-434-20 69452-434-30 69452-435-13 69452-435-20 69452-435-30	Medication guide	Prescribing Information
Dofetilide Capsules 0.125mg; 0.25mg; 0.5mg	69452-131-17 69452-132-17 69452-133-17	Medication guide	Prescribing Information
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets	69452-206-20	Patient Information Leaflet	Prescribing Information
Enalapril Maleate Oral Solution 1mg/mL	69452-237-46	N/A	Prescribing Information
Ergocalciferol Capsules, USP 1250 mcg	69452-151-20	N/A	Prescribing Information
Eszopiclone Tablets, USP 1mg; 2mg; 3mg	69452-347-13 69452-347-20 69452-348-20 69452-349-20	Medication guide	Prescribing Information
Ethosuximide Capsules, USP 250 mg		Medication guide	Prescribing Information
Fluvoxamine Maleate Extended-Release Capsules 100 mg: 150 mg	69452-182-13 69452-182-32 69452-183-13 69452-183-32	Medication guide	Prescribing Information
Fluvoxamine Maleate Tablets, USP (uncoated) 25 mg; 100 mg	69452-454-20 69452-454-30 69452-454-32 69452-455-20 69452-455-30 69452-455-32	Medication guide	Prescribing Information
Fluvoxamine Maleate Tablets, USP 25 mg (coated); 50 mg (uncoated); 100 mg (coated)	69452-287-20 69452-288-20 69452-288-30 69452-288-32 69452-289-20	Medication guide	Prescribing Information
Granisetron Hydrochloride Tablets, USP 1mg	69452-350-01 69452-350-11 69452-350-92	N/A	Prescribing Information
Hydroxyzine Hydrochloride Oral Solution, USP 10 mg/5 mL	69452-395-88	N/A	Prescribing Information
Ibandronate Sodium Tablets 150mg	69452-378-74	Medication guide	Prescribing Information
Ivabradine Tablets 5 mg and 7.5 mg	69452-190-17 69452-190-30	Medication guide	Prescribing Information
Ketorolac Tromethamine Tablets, USP 10mg	69452-275-20	Medication guide	Prescribing Information
Levetiracetam Oral Solution, USP 100 mg/mL	69452-412-88	Medication guide	Prescribing Information
Loperamide Capsules, 2mg	69452-271-20 69452-271-30	N/A	Prescribing Information
Metformin Hydrochloride Oral Solution, 500 mg /5 mL	69452-380-88	Patient Information Leaflet	Prescribing Information
Methimazole Tablets USP, 5 mg and 10 mg	69452-328-20 69452-329-20		Prescribing Information
Modafanil Tablets USP 100 mg and 200 mg	69452-342-13 69452-342-19 69452-342-20 69452-343-13 69452-343-19 69452-343-20	Medication guide	Prescribing Information
Naratriptan Tablets USP 1 mg and 2.5 mg	69452-340-60 69452-340-72 69452-341-60 69452-341-72	Patient Information Leaflet	Prescribing Information
Nicardipine Hydrochloride Capsules, 20 mg and 30 mg	69452-436-19 69452-437-19	N/A	Prescribing Information
Nimodipine Capsules, 30mg	69452-209-13 69452-209-20	N/A	Prescribing Information
Oxcarbazepine Oral Suspension, USP 300mg/5mL	69452-125-50	Medication guide Instructions For Use	Prescribing Information
Paricalcitol Capsules 1 mcg, 2mcg,4 mcg	69452-145-13 69452-146-13 69452-147-13	N/A	Prescribing Information
Prochlorperazine Maleate Tablets 5 mg and 10 mg	69452-471-20 69452-471-32 69452-472-20 69452-472-32	N/A	Prescribing Information
Progesterone Capsules USP 100 mg and 200 mg	69452-233-20 69452-234-20	Patient Information Leaflet	Prescribing Information
Ropinorole Tablets USP 0.25 mg , 0.5 mg , 1 mg, 2 mg, 3 mg, 4 mg and 5 mg	69452-356-20 69452-357-20 69452-358-20 69452-359-20 69452-360-20 69452-361-20 69452-362-20	Medication guide	Prescribing Information
Rufinamide Oral Suspension 40mg/mL	69452-223-84	Medication guide Instructions For Use	Prescribing Information
Sevelamer Carbonate for Oral Suspension 0.8 g and 2.4 g	69452-126-19 69452-126-60 69452-127-19 69452-127-60	N/A	Prescribing Information
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate solution 17.5, 3.13, 1.6 g per 6 oz	69452-428-62	Medication guide Instructions For Use	Prescribing Information
Sumatriptan Tablets USP, 25 mg, 50 mg, and 100 mg	69452-344-60 69452-344-72 69452-345-60 69452-345-72 69452-346-60 69452-346-72	Patient Information Leaflet	Prescribing Information
Terazosin capsules, USP 1 mg, 2mg, 5 mg and 10 mg	69452-330-20 69452-330-32 69452-331-20 69452-331-32 69452-332-20 69452-332-32 69452-333-20 69452-333-32	Patient Information Leaflet	Prescribing Information
Terbinafine Tablets USP 250 mg	69452-351-13 69452-351-20	Medication guide	Prescribing Information
Tetrabenazine Tablets 12.5mg; 25mg	69452-117-21 69452-118-21	Medication guide	Prescribing Information
Theophylline Extended-Release Tablets 300 mg	69452-267-20		Prescribing Information
Valproic Acid Capsules, USP 250mg	69452-150-20	Medication guide	Prescribing Information
Zaleplon Capsules USP 5 mg and 10 mg	69452-364-20 69452-365-20	Medication guide	Prescribing Information