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Mucus Relief Cold and Sinus Maximum Strength

Dosage form: liquid
Ingredients: GUAIFENESIN 400mg in 20mL, ACETAMINOPHEN 650mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Western Family Foods, Inc.
NDC Code: 55312-235

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mucus Relief Cold and Sinus Maximum Strength DELISTED

Drug Facts

Guaifenesin 400 mg

Acetaminophen 650mg

Phenylephrine HCl 10mg

Purpose

Expectorant

Pain Reliever, Fever Reducer

Nasal Decongestant

Uses
  • 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, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 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
  • persistent or chronic cough such as occurs with smoking, astha, chrinic 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
  • cough lasts more than 7 days, comes back, or occurs with 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 1-800-222-1222 immediately.  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 exceed recommended dosage
  • use dosage cup provided
  • do not take more than 6 doses in a 24 hour period
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL=milliliter
  • children under 12 years-do not use
  • adults and children 12 years and older-20mL every 4 hours

Other information
  • each 20mL contains potassium 6mg, sodium 13mg
  • store at room temperature
  • do not refrigerate

Inactive ingredients

citric acid, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Principal Display Panel

Maximum Strength Mucus Relief Cold and Sinus

Acetaminophen, Aches and Fever

Guaifenesin, Chest Congestion and Mucus

Phenylephrine HCI Stuffy Nose

For Ages 12 and Over

compare to the active ingredients

of Mucinex Fast Max

Cold & Sinus Maximum Strength

Proudly distributed by Western Family Foods, Inc.

PO Box 4057

Portland, OR 97208 U.S.A.

Copyright 2013 Marca Registrada

www.westernfamily.com

6 FL OZ 177 mL

Package Label

WESTERN FAMILY Mucus Relief Cold and Sinus Maximum Strength

MUCUS RELIEF COLD AND SINUS  MAXIMUM STRENGTH
mucinex cold and sinus maximum strength liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-235
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 20 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XANTHAN GUM 
WATER 
DISODIUM EDTA-COPPER 
PROPYL GALLATE 
SODIUM BENZOATE 
SUCRALOSE 
SORBITOL 
SODIUM CITRATE 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
PROPYLENE GLYCOL 
CITRIC ACID ACETATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-235-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/201304/30/2018
Labeler - Western Family Foods, Inc. (192166072)

Revised: 09/2017
 
Western Family Foods, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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