TUSSNEX FM COLD AND SINUS- acteaminophen, guaifenesin, phenylephrine hcl liquid

Tussnex FM Cold and Sinus by

Drug Labeling and Warnings

Tussnex FM Cold and Sinus 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)

Acetaminophen 650 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

KEEP OUT OF REACH OF CHILDREN

Uses

• temporarily relieves these common cold and flu symptoms:
• nasal congestion
• sinus congestion and pressure
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

• Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 doses in 24 hours, which is maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product
• Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for children under 12 years of age
• 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

• liver disease
• 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)

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• do not take more than 6 doses in any 24 hour period
• measure only with dosing cup 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, FD and 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 Cold and Sinus

Maxumum Strength Tussnex FM

Cold and Sinus

Acetaminophen

Pain reliever/Fever reducer

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Multi-symptom

Relieves Pain and Reduces Fever

Relieves Nasal and chest congestion

Thins and loosens mucus

For ages 12 and over

INGREDIENTS AND APPEARANCE

TUSSNEX FM COLD AND SINUS 
acteaminophen, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-616
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 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: 53041-616-58	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)