Guaifenesin description, usages, side effects, indications, overdosage, supplying and lots more!

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Guaifenesin

Physicians Total Care, Inc.

Q-Tussin DM 0855


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Cough suppressant

Expectorant

  • 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

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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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

  • 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.

citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

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



Guaifenesin

Guaifenesin

Guaifenesin and Dextromethorphan Hydrobromide SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-1986(NDC:0603-0855)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
GLUCOSE OXIDASE
water
saccharin sodium
SODIUM BENZOATE

Product Characteristics

Color
RED (clear, red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-1986-0 473 in 1 BOTTLE, PLASTIC
2 NDC:54868-1986-1 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1999-11-16


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Be sure to consult your doctor before taking any medication!
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