Q TUSSIN DM- dextromethorphan hbr and guaifenesin syrup

Q Tussin DM by

Drug Labeling and Warnings

Q Tussin DM by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL = 1 tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

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

Warnings

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

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.

PREGNANCY OR BREAST FEEDING

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.

Directions

• 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 children12 years and over:

  2 teaspoons; every 4 hours

• children under12 years:

  do not use

Other information

• 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

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

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Q TUSSIN DM 
dextromethorphan hbr and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-040(NDC: 0603-0855)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	RED (clear, red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-040-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/1995

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-040) , RELABEL(63187-040)