CVS MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin solution 
CVS PHARMACY

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 Adult Cough+Chest Congestion DM Drug Facts

Active ingredients (in each 20 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough last for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information

each 20 mL contains: sodium 7 mg
store at room temperature. Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C Red No. 40, flavor, menthol, microcrystalline cellulose, povidone, propylene glycol, purified water, potassium citrate, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

*Compare to the active ingredients of Robitussin® Cough + Chest Congestion DM*

NDC# 51316-740-04

MAXIMUM STRENGTH

Adult

Cough+Chest

Congestion DM

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Relieves Chest Congestion
Controls cough
Thins & Loosens Mucus

Natural Raspberry Flavor

For Ages 12 & Over

4 FL OZ (118 mL)

Distributed By:

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Cough + Congestion DM.

Package Label For 4 FL OZ (118 mL)

CVS Max Strength Dextrometorphan HBr, Guaifenesin

Package Label For 8 FL OZ (237 mL)

CVS Maximum Strength Adult Cough+Chest Congestion 8 FLoz 237 ml
CVS  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-740
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
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-740-041 in 1 CARTON02/17/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51316-740-081 in 1 CARTON02/17/2023
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/17/2023
Labeler - CVS PHARMACY (062312574)

Revised: 3/2023
Document Id: d7bace4f-a779-40dc-83bb-bc041530641e
Set id: 3148f80f-8a0d-4b6c-85be-79085fc04444
Version: 2
Effective Time: 20230303
 
CVS PHARMACY