Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections
Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Dosage and administration
do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age age (yr) dose (tsp) adults and children 12 years and over 2 teaspoons every 4 hours children under 12 years do not use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
WARNINGS SECTION
Do not use 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
OTC - ASK DOCTOR SECTION
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
OTC - STOP USE SECTION
Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
DOSAGE & ADMINISTRATION SECTION
do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years of age
age (yr)
dose (tsp)
adults and children 12 years and over
2 teaspoons every 4 hours
children under 12 years
do not use
Other information
SPL UNCLASSIFIED SECTION
store at 15° to 30°C (59° to 86°F)
dosage cup provided
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive ingredients
INACTIVE INGREDIENT SECTION
citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate
SPL UNCLASSIFIED SECTION
Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811
Rev. 7/09 R4 8281171 0855
Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 54868-1986-1 118 mL image of 118 mL package label
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
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