The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories, Inc for the product Dometuss (NDC 65852-002). 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 otc - purpose, otc - active ingredient, warnings, otc - ask doctor, otc - when using, otc - stop use, if pregnant, keep out, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Active Ingredients ( in each 5ml-teaspoonful)
Chlorpheniramine Maleate 2mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Warnings: Do not use
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.
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
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 or breast feeding ask a health professional before use.
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 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: 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.
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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.
Dometuss
Antihistamine/Cough Suppressant/Nasal Decongestant
Sugar, Alcohol, And Dye
Free
Grape Flavor
4 fl oz ( 118 ml)
* Please review the disclaimer below.
