Gencontuss Solution
FDA Label NDC 52083-650
11 label sections · Submitted to the FDA by Kramer Novis · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Gencontuss (NDC 52083-650). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 5ml tsp), purposes, uses, warnings:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5Ml Tsp)
Chlorpheniramine Maleate, 2 mg
Dextromethorphan HBr, 10 mg
Phenylephrine HCl, 5 mg
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
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:
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.
Otc - 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
• 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
• 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
citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.
Questions Or Comments?
call weekdays from 8 AM to 4 PM AST at 1.787.767.2072
Packaging
Gencontuss (52083650 2)
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