Other
Drug Facts
Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
Dometuss-g
FDA Label NDC 53809-250
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Domel for the product Dometuss-g (NDC 53809-250). 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 other, otc - purpose, uses, warnings, do not use, do not give this product if you have, ask a doctor before use if you have, stop using this product and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each tablet) | Purpose | |
|---|---|---|
| Guaifenesin | 200 mg | Expectorant |
| Dextromethorphan HBr | 20 mg | Cough Suppressant |
| Phenylephrine HCl | 10 mg | Nasal Decongestant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
- calm the cough control center, and relieves coughing.
- Temporarily relief nasal congestion due to the common cold
- hay fever or other upper respiratory allergies
- sinus congestion and pressure
Warnings
- Do not exceed recommended dosage
If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
Do Not Use
- if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product
Do Not Give This Product If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask A Doctor Before Use If You Have
- liver disease
- if you are taking the blood thinning drug warfarin.
Stop Using This Product And Ask A Doctor If
- new symptoms occur
- symptoms do not improve within 7 days or are accompanied by fever.
- pain or fever persists or gets worse. These could be signs of a serious condition
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast-feeding, ask a health professional before use.
Directions
Do not take more than 6 doses in any 24 hours period.
| Age | Dose |
|---|---|
| adults and children 12 years of age and over | 1 tablets every 4 hours. |
| children 6 to 12 years of age | 1/2 tablet every 4 hours. |
| children under 6 years of age | Consult a doctor. |
Other Information
- store at room temperature 15°- 30°C (59° - 86°F).
Tamper Evident
Do not use if there is evidence of tampering.
Inactive Ingredients
Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.
Questions Or Comments?
Calle de Diego #488
San Juan P.R. 00924
Phone: 787-767-3246
For more information visit
www.domelpharma.com
Principal Display Panel - 100 Tablet Bottle Label
NDC 53809-250-01
DOMETUSS-G
DEXTROMETHORPHAN HBr/
PHENYLEPHRINE HCl / GUAIFENESIN
- Cough Suppressant
- Nasal Decongestant
- Expectorant
100 TABLETS
Principal Display Panel (100 Tablet Bottle Label)
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