Label: ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride tablet
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- NDC Code(s): 63102-401-60
- Packager: Actipharma, Inc
- 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 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each tablet)
- Purpose
- Keep out of reach of children.
- INDICATIONS & USAGE
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Warnings
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
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma • heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus
• difficulty in urination due to enlargement of the prostate glandDo not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When using this product
• excitability may occur, especially in children
• may cause drowsiness
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machineryStop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur
• if symptoms do not improve within 7 days or are accompanied by fever
• new symptoms occurIf pregnant or breast feeding, ask a health professional before use.
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours not to exceed 4 tablets in 24 hours or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours not to exceed 2 tablets in 24 hours or as directed by a doctor Children under 6 years of age Consult a doctor - Inactive ingredients
- Other information
- Questions or Comments?
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SPL UNCLASSIFIED SECTION
Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787) 608-0882
*Conex® Tablets is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
Contains the same active ingredients as Conex® Tablets*
ANTIHISTAMINE • NASAL DECONGESTANT
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
- Packaging
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INGREDIENTS AND APPEARANCE
ACTICON
dexbrompheniramine maleate, pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-401 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 MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code A401 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-401-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/13/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/13/2015 Labeler - Actipharma, Inc (079340948)
