CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid 
CVS PHARMACY, INC
Reference Label Set Id: 7f4ccd7c-9b17-428b-8cdf-42237728f9b2

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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CVS Maximum Strength Severe Congestion and Cough Cooling Menthol Flavor

Drug Facts

Active ingredients
(in each 20 mL)
Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
nasal congestion due to a cold
temporarily helps you cough less

Warnings

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.

Ask a doctor before use if you have

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)

When using this product do not use more than directed

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
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 overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

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
mL = milliliter
adults and children 12 years of age 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 6 mg
very low sodium
store at room temperature
do not refrigerate
dosing cup provided

Inactive Ingredients

anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC# 69842-767-06

Compare to Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough Clear and Cool® Active Ingredients*

Maximum Strength

Severe Congestion & Cough

 

Dextromethorphan HBr Cough Suppressant
Guaifenesin Expectorant
Phenylephrine HCl Nasal Decongestant

Cooling Menthol Flavor

Naturally and Artificially Flavored

6 FL OZ (180 mL)

For Ages 12+

Tamper evident: do not use if printed seal under cap is broken or missing.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast -Max® Maximum Strength Severe Congestion & Cough Clear & Cool™.

CVS Maximum Strength Severe Congestion & cough
CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-767
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide20 mg  in 20 mL
guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ) guaifenesin400 mg  in 20 mL
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
edetate disodium (UNII: 7FLD91C86K)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
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)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMENTHOL (Cooling Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-767-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2020
Labeler - CVS PHARMACY, INC (062312574)

Revised: 9/2023
Document Id: b0215cc4-5274-4460-8716-ec190132d6a1
Set id: bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9
Version: 5
Effective Time: 20230914
 
CVS PHARMACY, INC