TUSSNEX FM SEVERE COUGH AND CONGESTION- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Tussnex FM Severe cough and congestion by

Drug Labeling and Warnings

Tussnex FM Severe cough and congestion by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

KEEP OUT OF REACH OF CHILDREN

Uses

• hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help you get to sleep
• nasal congestion due to a cold

Warnings

Do not use

• for children under 12 years of age
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for 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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever
• cough comes back, or occurs with 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.

Directions

• do not take more than 6 doses in 24-hour period
• measure only with dosing coup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
• Children under 12 years of age: Do not use

Other information

• each 20 mL contains: sodium 20 mg
• store between 15-30oC(59-86oF)
• do not refrigerate
• dosing cup provided

Inactive ingredients

citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

PDP

compare to the active ingredients in Mucinex Fast Max Severe Cough and congestion

Maximum strength Tussnex FM

Severe Cough and Congestion

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Relieves:

Soothes cough

Thins and loosens mucus

Relieves Nasal and chest congestion

For ages 12 and over

INGREDIENTS AND APPEARANCE

TUSSNEX FM SEVERE COUGH AND CONGESTION 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-617
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-617-58	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2012

Labeler - Guardian Drug Company (119210276)