Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SEVERE COLD AND FLU RELIEF DAYTIME- acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid 
The Kroger Co.

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.

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Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • nasal and sinus congestion
    • minor sore throat
    • headache
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 inclide:

  • skin reddening
  • blisters
  • rash

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

  • 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. 
  • 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.
  • if you are allergic to acetaminophen
  • in a child under 12 years of age

Ask a doctor before use if you have

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

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 a 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 use more than directed
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • adults and children 12 years and over : 30 mL every 4 hours while symptoms last
  • chlldren under 12 years of age: do not use 

Other information

  • each 30 mL contains: potassium 20 mg, sodium 18 mg 
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

acesulfame potassium, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

COMPARE TO the  active ingredients of THERAFLU® EXPRESSMAX® SEVERE COLD & FLU *See back panel

Flu Relief Maximum Strength

DAYTIME SEVERE COLD & FLU 

Acetaminophen 650 mg, Pain Reliever/Fever Reducer

Dextromethorphan HBr 20 mg, Cough Suppressant/

Guaifenesin 400 mg Expectorant/

Phenylephrine HCI 10 mg Nasal decongestant

Relieves

  • Body ache
  • Fever
  • Chest congestion
  • Nasal congestion
  • Headache
  • Cough
  • Sore throat pain

For ages 12 years and over

Alcohol Free

FL OZ (mL)

Berry Flavor

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

*THERAFLU® IS A REGISTERED TRADEMARK OF GSK CONSUMER HEALTHCARE, PHILADELPHIA, PA 19112. GSK CONSUMER HEALTHCARE IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT

DISTRIBUTED BY THE KROGER CO.

CINCINNATI,OHIO 45202

www.kroger.com

Product Label

Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg

KROGER Flu Relief Maximum Strength DayTime Severe Cold & Flu

SEVERE COLD AND FLU RELIEF  DAYTIME
acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-716
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
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)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-716-08245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/31/2018
Labeler - The Kroger Co. (006999528)

Revised: 12/2019
 
The Kroger Co.


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