Gencontuss
Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride · Solution · Oral
Active ingredient
Active ingredients (in each 5mL tsp) Chlorpheniramine Maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg
Purpose
Purposes Antihistamine Cough suppressant Nasal decongestant
Uses
Uses
• For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever.
• Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold.
• Temporarily restores freer breathing through the nose.
Warnings
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 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
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• difficulty in urination 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 before use if you are taking sedatives or tranquilizers When using this product
• do not exceed recommended dosage
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur
• excitability occurs, especially in children
• symptoms do not improve within 7 days or are accompanied by fever
• cough persists for more than 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 health professional before use. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Keep out of reach of children
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Directions
Directions
• Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and older 2 teaspoonfuls (10 mL) every 4 hours. Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours. Children 2 to under 6 years of age Ask a doctor.
Other information
Other information
• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30⁰C(59-86⁰F).
• Avoid excessive heat or humidity.
Inactive ingredients
Inactive Ingredients citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.
Questions?
Questions or comments? call weekdays from 8 AM to 4 PM AST at 1.787.767.2072
Label text from the FDA structured product label by KRAMER NOVIS (revised Dec 4, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Chlorpheniramine Maleate in 1 product
- Dextromethorphan Hydrobromide in 1 product
- Phenylephrine Hydrochloride in 1 product
Gencontuss NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 52083-650 | Chlorpheniramine Maleate 2 mg/5mL; Dextromethorphan Hydrobromide 10 mg/5mL; Phenylephrine Hydrochloride 5 mg/5mL Solution | KRAMER NOVIS | OTC MONOGRAPH DRUG |
Gencontuss recalls
- D-1497-2019 Jul 31, 2019 · Class II · Terminated
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Frequently asked questions
What is Gencontuss used for?
Uses • For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever. • Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold. • Temporarily restores freer breathing through the nose.
Who makes Gencontuss?
Gencontuss is listed by 1 labeler in the FDA NDC directory, including KRAMER NOVIS.
Has Gencontuss been recalled?
The FDA enforcement database lists 1 recall for Gencontuss, most recently D-1497-2019 (class ii): CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing…