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Drug Facts
Dometuss
FDA Label NDC 53809-202
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 Laboratories for the product Dometuss (NDC 53809-202). 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, 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, stop use 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 5 ml-teaspoonful) | Purpose |
|---|---|
| Chlorpheniramine Maleate 4 mg | Antihistamine |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCl 10 mg | 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.
Stop Use And Ask A Doctor If
you get nervous, dizzy, or sleepless.
- cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent 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 | Take 1 teaspoonful (5 mL) every 4 hours |
| Children 6 to under 12 years of age | Take 1/2 teaspoonful (2.5 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,grape flavor,glycerin hydroxyethylcellulose methylparaben,propylen glycol, propylparaben, purified water,sodiumcitrate,and sucralose.
Questions Or Comments?
Please call (787) 767-3246
Principal Display Panel - 118 Ml Bottle Label
NDC 53809-202-04
DOMETUSS
Antihistamine/Cough Suppressant
/Nasal Decongestant
Sugar, Alcohol, And Dye
Free
Grape Flavor
4 fl. oz (118 ml)
Principal Display Panel (118 mL Bottle Label)
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