Label: KROGER MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH- dextromethorphan hbr, guaifenesin, and phenylephrine hcl liquid
- NDC Code(s): 30142-738-06
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 24, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves:
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- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
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- the intensity of coughing
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- the impulse to cough to help you get to sleep
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- nasal congestion due to a cold
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Warnings
Do not use
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- 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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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- cough that occurs with too much phlegm (mucus)
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Directions
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- do not take more than 6 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- mL = milliliter
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- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours.
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- children under 12 years of age: Do not use.
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
NDC 30142-738-06
Compare to Mucinex® Fast- Max® Maximum Strength Severe Congestion & Cough Active Ingredients*
Maximum Strength
Severe Congestion & Cough
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant- •
- Control Cough
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- Relieves Nasal and Chest Congestion
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- Thins & loosens mucus
For Ages 12+
6 FL OZ (180 mL)
Tamper evident: do not use if printed seal under cap is broken or missing.
*This product is not manufactured or distributed by RB Health (US) LLC, the distributor of Mucinex® and Fast-Max® Maximum Strength Severe Congestion & Cough.
Distributed by:
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INGREDIENTS AND APPEARANCE
KROGER MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH
dextromethorphan hbr, guaifenesin, and phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-738 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide 20 mg in 20 mL guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ) guaifenesin 400 mg in 20 mL phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) FD&C Blue NO. 1 (UNII: H3R47K3TBD) FD&C Red NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) propylene glycol (UNII: 6DC9Q167V3) propyl gallate (UNII: 8D4SNN7V92) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) xanthan gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-738-06 180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/03/2020 Labeler - KROGER COMPANY (006999528)