FDA Label for Dometuss-nr
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING
- STOP USING THIS PRODUCT AND ASK A DOCTOR IF
- WHEN USING THIS PRODUCT
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE LABEL
Dometuss-nr Product Label
The following document was submitted to the FDA by the labeler of this product Domel Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each tablet) | Purpose | |
|---|---|---|
| Dextromethorphan HBr | 20 mg | Cough Suppressant |
| Chlorpheniramine Maleate | 4 mg | Antihistamine |
| Phenylephrine HCl | 10 mg | Nasal decongestant |
Uses
- Temporarily relieves
- runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever.
- Nasal congestion due to the common cold.
- coughs due to minor throat and bronchial irritation as may occur with a cold.
Warnings
- Do not exceed recommended dosage
Do Not Use
- if you are now taken a prescription Monoaminooxidase 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.
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- trouble urinating due to enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm(mucus)
- a breathing problem 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.
Stop Using This Product And Ask A Doctor If
- you get nervous, dizzy or sleepless
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.
When Using This Product
- Excitability may occur, especially in children
- May cause drowsiness
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- Avoid alcoholic beverages while taking this product
- Use caution when driving motor vehicle or operating machinery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms.
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 tablets in 24 hours, or as directed by a doctor.
| Age | Dose |
|---|---|
| adults and children 12 years of age and over | 1 tablet every 4 hours. |
| children under 12 years of age | Consult a doctor before use. |
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
Carbomer, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Talc.
Questions Or Comments?
Please call (787) 767-3246
Principal Display Panel - 100 Tablet Bottle Label
NDC 53809-240-01
DOMETUSS-NR
DEXTROMETHORPHAN HBr/ CHLORPHENIRAMINE
MALEATE/ PHENILEPHRINE HCl
- Cough Suppressant
- Antihistamine
- Nasal decongestant
100 TABLETS
* Please review the disclaimer below.