Label: PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release
- NDC Code(s): 37808-204-21, 37808-204-69
- Packager: HEB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT (IN EACH TABLET)
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- symptoms do not get better within 7 days or occur with a fever
- you get nervous, dizzy, or sleepless
Keep out of reach of children.
- adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
- children under 12 years: ask a doctor
- OTHER INFORMATION
- store at 59° to 77° F in a dry place
- protect from light
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- Nasal & Sinus Congestion due to Colds & Allergies
- Sinus Pressure
- Maximum Strength
- INGREDIENTS AND APPEARANCE
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-204 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 204 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-204-69 10 in 1 BLISTER PACK 2 NDC:37808-204-21 20 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077442 04/28/2006 Labeler - HEB (007924756) Registrant - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(37808-204)