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adult cold, flu and sore throat

Dosage form: liquid
Ingredients: ACETAMINOPHEN 6501 in 20mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: Mckesson
NDC Code: 62011-0193

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.

adult cold, flu and sore throat multi-symptom

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses

temporarily relieves these common cold and flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • cough due to minor throat and minor bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • 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 Mucinex Fast-Max Cold, Flu and Sore Throat active ingredients

adult cold, flu and sore throat

multi-symptom

pain reliever/Fever reducer, acetaminophen

Cough Suppressant, dextromethorphan HBr

expectorant, guaifenesin

nasal congestion, phenylephrine HCl

calms headaches and fevers

relieves nasal and chest congestion,

soothes cough, thins and loosens mucus

For Ages 12 and Over

MAXIMUM STRENGTH

6 FL OZ (177 mL)

ADULT COLD, FLU AND SORE THROAT  
acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0193
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650   in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
PROPYL GALLATE 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:62011-0193-1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2012
Labeler - Mckesson (177667227)

 
Mckesson

← See all adult cold, flu and sore throat brands

Medically reviewed on Jul 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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