NDC | 69367-199-01 |
Set ID | 77679ca2-d913-44dc-826f-8b67d26793d7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Westminster Pharmaceuticals, LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Do not exceed recommended dosage.
Do not use this product
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- exctability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- SPL UNCLASSIFIED SECTION
- Directions
- Other Information
- Inactive ingredients
- Questions? Comments?
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
-
INGREDIENTS AND APPEARANCE
DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE
doxylamine succinate and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-199 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 7.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 14mm Flavor Imprint Code WP;199 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-199-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/25/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/25/2018 Labeler - Westminster Pharmaceuticals, LLC (079516651)