Label: GENCONTUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
- NDC Code(s): 52083-650-16
- Packager: KRAMER NOVIS
- 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 October 15, 2022
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 5mL tsp)
- Purpose
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Uses
• For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy watery eyes due to hay fever or other upper respiratory allergies.
• Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold.
• Temporarily relieves nasal congestion and restores freer breathing through the nose.
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Warnings
Do not use
• To sedate a child or to make a child sleepy.
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• Heart disease • Thyroid disease • Glaucoma • High blood pressure • Diabetes • Trouble urinating due to enlargement of the prostate gland • Cough that occurs with too much phlegm (mucus) • Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist: If you are taking sedatives or tranquilizers
When using this product
• DO NOT EXCEED RECOMMENDED DOSE.
• Marked drowsiness may occur • Excitability may occur, especially in children • Avoid alcoholic beverages • Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Be careful when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
• Nervousness, dizziness, or sleeplessness occur. • Symptoms do not improve within 7 days or are accompanied by fever• Cough persists for 1 week, tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a healthcare professional before use.
- Directions
- Other information
- Inactive Ingredients
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SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Rycontuss®*
ANTIHISTAMINE
COUGH SUPPRESSANT
NASAL DECONGESTANT
Cherry Flavor
Manufactured in the USA for Kramer Novis, San Juan, PR 00917. Tel:(787) 767-2072 www.kramernovis.com
*Rycontuss® is a registered trademark of Okendpharma Inc. This product is not manufactured, distributed or marketed by Okendpharma Inc.
- Packaging
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INGREDIENTS AND APPEARANCE
GENCONTUSS
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-650 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color red (Clear Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-650-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/08/2015 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)
