Skip to Content

← See all Cold, Flu and Sore Throat Maximum Strength brands

Cold, Flu and Sore Throat Maximum Strength

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 20mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 20mL, GUAIFENESIN 400mg in 20mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 20mL
Labeler: L.N.K. International, Inc.
NDC Code: 50844-005

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.

Quality Plus 44-005-Liquid

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
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • temporarily promotes nasal and/or sinus drainage
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • for children under 12 years of age

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • thyroid disease
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 6 doses in any 24-hour period
  • mL=milliliter; FL OZ=fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years: do not use

Other information
  • each 20 mL contains: sodium 10 mg
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions or comments? 1-800-426-9391

Principal Display Panel

QUALITY
+PLUS

NDC 50844-005-45

*Compare to active ingredients
in Mucinex® FAST-MAX™
Cold, Flu & Sore Throat

MAXIMUM STRENGTH

COLD, FLU &
SORE THROAT

 Acetaminophen
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Pain Reliever/
Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant

6 FL OZ (177 mL)

Berry
Flavored

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING

*This product is not manufactured or
distributed by Reckitt Benckiser LLC, owner
of the registered trademark Mucinex®
FAST-MAX™ Cold, Flu & Sore Throat.

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

50844         ORG121600545

Quality Plus 44-005

COLD, FLU AND SORE THROAT  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  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 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SODIUM METABISULFITE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-005-45177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2017
Labeler - L.N.K. International, Inc. (038154464)

Revised: 06/2017
 
L.N.K. International, Inc.

← See all Cold, Flu and Sore Throat Maximum Strength brands

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.

Hide