Label: ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid
- NDC Code(s): 63102-105-16
- 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.
Updated December 5, 2018
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- Drug Facts
- Active Ingredients (in each 5 mL tsp)
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper
• relieves sinus congestion and pressure, helps decongest sinus openings and passages
• restores freer breathing through the nose
• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes • nasal congestion
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 • difficulty in urination due to enlargement of the prostate gland
Do 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 effect
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur • if symptoms do not improve within 7 days or are accompanined by fever • new symptoms occur
If pregnant or breast feeding, ask a health professional before use.
• Adults and children 12 years of age and over: Take 2 teaspoonfuls (10 mL) every 4-6 hours as needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 6-12 years: Take 1 teaspoonful (5 mL) every 4-6 hours as needed, do not exceed 2 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children under 6 years of age: consult a doctor.
- Other Information:
- Inactive Ingredients:
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 1 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-105-16 480 mL in 1 PACKAGE; Type 0: Not a Combination Product 07/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/14/2016 Labeler - ACTIPHARMA, INC. (079340948) Registrant - ACTIPHARMA, INC. (079340948)