NDC | 0295-5307-17, 0295-5307-28 |
Set ID | 3d6e56ad-d31b-4ef6-9690-f18b1ee45664 |
Category | HUMAN OTC DRUG LABEL |
Packager | Denison Pharmaceuticals, LLC. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- USES
- Keep out of reach of children
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
-
WARNINGS
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - Ask a Doctor
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- OTHER INFORMATION
- SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID
-
INGREDIENTS AND APPEARANCE
SAFETUSSIN PM
dextromethorphan doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-5307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 5 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 3.125 mg in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) MINT (UNII: FV98Z8GITP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-5307-17 1 in 1 CARTON 01/01/2017 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0295-5307-28 1 in 1 CARTON 01/01/2017 11/07/2019 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2017 Labeler - Denison Pharmaceuticals, LLC. (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC. 001207208 manufacture(0295-5307)