Label: ZEPHREX-D- pseudoephedrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 53240-151-01 - Packager: Westport Pharmaceuticals
- 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 May 15, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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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
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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)
