NDC | 53240-151-01 |
Set ID | d327b4ea-a232-4102-bd74-141196f687e0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Westport Pharmaceuticals |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
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
• heart disease • high blood pressure • thyroid disease • diabetes
• trouble urinating due to an enlarged prostate gland
When using this product do not exceed recommended dose
Stop and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
If pregnant or breast-feeding, ask a health professional before use.
-
DOSAGE & ADMINISTRATION
Directions: remove pill from sealed, plastic packaging before ingesting
swallow whole – do not crush, chew or dissolve
adults and children 12 years and over • take 2 pills every 4 to 6 hours
• do not take more than 8 pills in 24 hours
children ages 6 to under 12 years • take 1 pill every 4 to 6 hours
• do not take more than 4 pills in 24 hours
children ages under 6 years do not use this product in children
under 6 years of age
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZEPHREX-D
pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53240-151 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GUAR GUM (UNII: E89I1637KE) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53240-151-01 24 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/15/2012 Labeler - Westport Pharmaceuticals (078368047) Registrant - Elge Inc. (610655136) Establishment Name Address ID/FEI Business Operations Elge Inc. 610655136 manufacture(53240-151)