NDC Code(s) : 43547-503-10, 43547-503-50, 43547-504-09, 43547-504-50
Packager : Solco Healthcare US, LLC.
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
| METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, EXTENDED RELEASE | ||||||||||||||||||||||||||||||||
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| METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, EXTENDED RELEASE | ||||||||||||||||||||||||||||||||
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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(43547-503, 43547-504) | |
PRINCIPAL DISPLAY PANEL
Container Label-500 mg-100 tablets
Rx only
NDC 43547-503-10
Metformin Hydrochloride Extended-Release Tablets, USP
Each extended-release tablet contains:
500 mg metformin hydrochloride, USP.
Usual Dosage: See package insert for prescribing information.
WARNING: Keep out of reach of children.
This package is child-resistant. 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].
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Product of China.
Rev.: 05/2022
PRINCIPAL DISPLAY PANEL
Container Label-1,000 mg-90 tablets
Rx only
NDC 43547-504-09
Metformin Hydrochloride Extended-Release Tablets, USP
Each extended-release tablet contains:
1,000 mg metformin hydrochloride, USP.
Usual Dosage: See package insert for prescribing information.
WARNING: Keep out of reach of children.
This package is child-resistant. 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].
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Product of China.
Rev.: 05/2022
