Neogen-d
FDA Label NDC 52083-699
Full FDA labeling including 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 Neogen-d (NDC 52083-699). 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 5 ml 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 5 Ml Tsp)
Dextromethorphan HBr, 30 mg
Guaifenesin, 200 mg
Phenylephrine HCL, 7.5 mg
Purposes
Antitussive
Expectorant
Nasal Decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
• temporarily relieves these symptoms occurring with the common cold, sinusitis, hay fever or other respiratory allergies.
• nasal congestion
• cough due to minor throat and bronchial irritation
Warnings
Do not use 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
• Heart disease • High blood pressure • Thyroid disease • Diabetes • Trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
When using this product do not use more than directed.
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, 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 out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not take more than 4 doses in any 24-hour period. Shake well before using.
| Every 6-8 hours | Adults and children 12 years of age and over | Take one teaspoonful (5 mL) |
| Children 6 to under 12 years of age | Take 1/2 teaspoonful (2.5 mL) | |
| Children under 6 years of age | Consult a doctor |
Other Information
• Store at controlled room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat or humidity.
• Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.
Inactive Ingredients
Potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sorbitol, vegetable glycerin, sucralose, raspberry flavor and purified water
Packaging
Syrup1 (Label 1)
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