Label: DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE tablet
- NDC Code(s): 69367-199-01
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 9, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- 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
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- SPL UNCLASSIFIED SECTION
- 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 tablet
Product 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)