Label: CONEX- dexbrompheniramine maleate, pseudoephedrine hcl tablet
- NDC Code(s): 54859-702-60
- Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- 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 December 23, 2020
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- ACTIVE INGREDIENT
-
PURPOSE
Uses
- Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- helps decongest sinus openings and sinus passages
- Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
- Temporarily alleviates the following symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.
-
WARNINGS
Warnings:
Ask a doctor before you use if you are
- taking sedatives or tranquilizers.
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- difficulty in urination due to the enlargement of the prostate gland.
- do not exceed the recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- nervousness, dizziness or sleepiness occur
- symptoms do not improve withing 7 days or occur with a fever
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
DO NOT USE
Do not use if you are 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 you are taking a prescription drug that contains MAOI;
ask your doctor or pharmacist before taking this product.
- DOSAGE & ADMINISTRATION
-
INDICATIONS & USAGE
Other Information: Store at controlled room temperature 20 - 25 degree celsius (68 - 77 degree fahrenheit); excursions permitted to
15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal
under cap. Do not use if there is evidence of tampering.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CONEX
dexbrompheniramine maleate, pseudoephedrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-702 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 2 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985) WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 13mm Flavor Imprint Code LLORENS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-702-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2007 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) Registrant - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)