Kroger Co. Fast Mucus Relief Drug Facts

Kroger Co. Fast Mucus Relief Drug Facts

Drug Labeling and Warnings

Drug Details

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FAST MUCUS RELIEF- acetaminophen, guaifenesin, phenylephrine hcl tablet, coated 
Kroger Company

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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Kroger Co. Fast Mucus Relief Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • fever
  • headache
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • 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 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 include:

  • skin reddening
  • blisters
  • rash

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

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

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
  • 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:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 10 caplets in any 24-hour period
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information

  • each caplet contains: sodium 4 mg
  • do not use if blister unit is broken or torn
  • store at 20-25˚C (68-77˚F)

Inactive Ingredients

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredients of MUCINEX® FAST-MAX® COLD & SINUS CAPLETS

See back panel

SEE NEW WARNINGS

FOR AGES 12+

MAXIMUM STRENGTH

Fast Mucus Relief

COLD & SINUS

Acetaminophen, Pain Reliever/Fever Reducer

Guaifenesin, Expectorant

Phenylephrine HCl, Nasal Decongestant

Relieves Headache & Fever

Relieves Nasal & Chest Congestion

Thins & Loosens Mucus

20 CAPLETS

actual size

Kroger Fast Mucus Relief Image 1
Kroger Fast Mucus Relief Image 2
FAST MUCUS RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code L145
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-511-0110 in 1 CARTON07/30/2014
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 30142-511-3915 in 1 CARTON12/11/2015
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/30/2014
Labeler - Kroger Company (006999528)

Revised: 12/2018
 
Kroger Company


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