FDA Label for Dometuss
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- TAMPER-EVIDENT DISCLOSURE
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Dometuss 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 5ml-teaspoonful) | Purpose |
|---|---|
| Chlorpheniramine Maleate 2mg | Antihistamine |
| Dextromethorphan HBr 10mg | Cough Suppresant |
| Phenylephrine HCl 5mg | Nasal Decongestant |
Use
- For 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 as may occur with the common cold.
- Temporarily restores freer breathing through the nose.
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 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
- thyroid disease
- trouble urinating due to enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm(mucus)
- a breathing problems 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.
Otc - When Using
- When using this product.
DO NOT EXCEED RECOMMENDED DOSAGE - may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may cause increased drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially with children.
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF you get nervous, dizzy, or sleepless.
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persitent headaches. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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 exceed more than 6 doses in any 24 hour period.
| Adults and children 12 years of age and over | 2 teaspoonful ( 10 ml ) every 4 hours. |
| Children 6 to under 12 years of age | 1 teaspoonful ( 5 ml ) every 4 hours. |
| Children under 6 years of age | Ask a doctor. |
Other Information
store at room temperature between 15°-30°C (59°-86°F).
Tamper-Evident Disclosure
Do not use this product if aluminum foil over bottle opening is torn, broken or missing.
Inactive Ingredients
Citric acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.
Questions Or Comments?
Please call (787) 767-3246.
Principal Display Panel - 118 Ml Bottle Label
NDC 53809-222-04
DOMETUSS
Antihistamine/Cough Suppressant/
Nasal Decongestant
Sugar, Alcohol, And Dye
Free
Grape Flavor
4 fl. oz (118 ml)
* Please review the disclaimer below.
