NDC | 76095-005-14 |
Set ID | 33231341-1aad-2dad-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | MIDWAY IMPORTING INC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each 10 mL)
- Purposes
- Uses
-
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 before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
-
Directions
- shake well before using
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product mL=milliliter
- this adult product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10mL every 4 hours
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- Package Label
-
INGREDIENTS AND APPEARANCE
XPECTO SOOTHING RELIEF
dextromethorphan hbr guaifenesin phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76095-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) MENTHOL (UNII: L7T10EIP3A) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color red (Cherry Red) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76095-005-14 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/09/2016 Labeler - MIDWAY IMPORTING INC (611851627)