NDC Code(s) : 43547-047-03, 43547-047-50, 43547-049-03, 43547-049-50, 43547-050-03, 43547-050-50, 43547-051-03, 43547-051-50
Packager : Solco Healthcare US, LLC
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
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| LABELER - Solco Healthcare US, LLC(828343017) |
| REGISTRANT - Prinston Pharmaceutical Inc.(967289799) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Zhejiang Huahai Pharmaceutical Co., LTD | 530732460 | MANUFACTURE(43547-047, 43547-049, 43547-050, 43547-051) | |
PRINCIPAL DISPLAY PANEL
Container Label-2.5 mg-30 tablets
Rx only
NDC 43547-047-03
Tadalafil tablets, USP
Tablets should not be split.
Entire dose should be taken.
Usual Dosage: See accompanying literature for dosage.
Each tablet contains 2.5 mg of tadalafil, USP.
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].
Warning: Keep out of reach of children.
Dispense in a tight container.
Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Revised.: 01/2022
Container Label-5 mg-30 tablets
Rx only
NDC 43547-049-03
Tadalafil tablets, USP
Tablets should not be split.
Entire dose should be taken.
Usual Dosage: See accompanying literature for dosage.
Each tablet contains 5 mg of tadalafil, USP.
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].
Warning: Keep out of reach of children.
Dispense in a tight container.
Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Revised.: 01/2022
Container Label-10 mg-30 tablets
Rx only
NDC 43547-050-03
Tadalafil tablets, USP
Tablets should not be split.
Entire dose should be taken.
Usual Dosage: See accompanying literature for dosage.
Each tablet contains 10 mg of tadalafil, USP.
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].
Warning: Keep out of reach of children.
Dispense in a tight container.
Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Revised.: 01/2022
Container Label-20 mg-30 tablets
Rx only
NDC 43547-51-03
Tadalafil tablets, USP
Tablets should not be split.
Entire dose should be taken.
Usual Dosage: See accompanying literature for dosage.
Each tablet contains 20 mg of tadalafil, USP.
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].
Warning: Keep out of reach of children.
Dispense in a tight container.
Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Revised.: 01/2022
