FDA Label for Dometuss
View Indications, Usage & Precautions
Dometuss Product Label
The following document was submitted to the FDA by the labeler of this product Dextrum Laboratories, Inc. 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.
Otc - Purpose
Anthistamine
cough suppresant
nasal descongestant.
Use
For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever.
Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
temporary restores freer breathing through the nose.
Otc - Active Ingredient
Active Ingredients ( in each 5ml-teaspoonful)
Chlorpheniramine Maleate 2mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Warnings
Warnings: Do not use
- To sedate a child or to make a child sleepy.
- If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn 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, asl a doctor or pharmacist before taking this product.
Otc - Ask Doctor
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.
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 carefulwhen driving a motor vehicleor 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 fiver, rash or persistent headaches. These could be signs of a serious condition.
If Pregnant
If pregnant or breast feeding ask a health professional before use.
Keep Out
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a poison Control center right away.
Directions
Directions:
Do not exceed more than 6 doses in a 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
Other information: store at room temperature between 15-30 C( 59-86 F)
Tamper-Evident
Tamper-Evident Disclosure: Do not use this product if aluminum foil over bottle opening is torn, broken or missing.
Inactive Ingredients
Inactive ingredients:
Citric Acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.
Question
Questions or Comments? Please call (787)767-3246.
Indication And Usage Section
:
Indication and usage section:
adults and children 12 year of age and over--- 2 teaspoonful (10ml) every 4 hours
Childrens 6 to under 12 years of age------ i teaspoonful (5ml) every 4 hours
Childrens under 6 years of age------ask a doctor
Do not exceed more than 6 doses in any 24 hours period.
Package Label.Principal Display Panel
Dometuss
Antihistamine/Cough Suppressant/Nasal Decongestant
Sugar, Alcohol, And Dye
Free
Grape Flavor
4 fl oz ( 118 ml)
* Please review the disclaimer below.
