CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH OVERNIGHT COLD AND FLU CLEAR AND COOL- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen and triprolidine hcl 
CVS

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.

----------

Maximum Strength Severe Congestion & Cough and Overnight Cold & Flu Value Pack

Drug Facts

Active ingredients (in each 20 mL)
Maximum Strength Severe Congestion & Cough
Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Expectorant

Nasal decongestant

Active ingredients (in each 20 mL)Purposes
Overnight Cold & Flu Clear & Cool

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Antihistamine/cough suppressant

Nasal decongestant

Triprolidine HCl 2.5 mg

Antihistamine

Uses

MAXIMUM STRENGTH SEVERE CONGESTION & COUGH

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

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 Centre 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
low sodium
store at room temperature
do not refrigerate
dosing cup provided

Inactive ingredients (Maximum strength mucus relief DM)

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

Uses (OVERNIGHT COLD & FLU CLEAR & COOL

temporarily relieves these common cold and flu symptoms:
cough
nasal congestion
minor aches and pains
sore throat
headache
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes due to hay fever
temporarily reduces fever
controls cough to help you get to sleep

Warnings

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

more than 4000 mg in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

If pregnant or breast feeding

ask a health professional before use

Keep Out of Reach of Children

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centre right away at 1-800-222-1222.

Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

Directions

do not take more than directed (see overdose warnings
do not take more than 4 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
adults and children 12 years of age and over: 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 10 mg
store at room temperature
do not refrigerate

Inactive ingredients (Overnight Cold & Flu)

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

Questions or comments?

(1-866-467-2748)

PRINCIPAL DISPLAY PANEL - Kit Carton

VALUE PACK

NDC 69842-967-12

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

Maximum Strength

Severe Congestion & Cough

Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant

Phenylephrine HCl • Nasal Decongestant

Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus

Cooling Menthol Flavor

Naturally and Artificially Flavored

For Ages 12+

6 FL. OZ. (180 mL)

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

Compare to Mucinex® Nightshift Cold & Flu Clear & Cool Active Ingredients**

Overnight Cold & Flu

Clear & Cool

Acetaminophen • Pain Reliever/Fever Reducer
Dextromethorphan HBr • Cough Suppressant
Phenylephrine HCl • Nasal Decongestant

Triprolidine HCl • Antihistamine

Maximum Strength per 4-hour dose

Night Time Relief for a Better Morning

Cough
Fever
Sore Throat
Runny Nose
Sneezing
Nasal Congestion

For Ages 12+

6 FL OZ (180 mL)

**This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu Clear & Cool.

DO NOT TAKE MAXIMUM STRENGTH SEVERE CONGESTION & COUGH & OVERNIGHT COLD & FLU CLEAR & COOL LIQUIDS AT THE SAME TIME.

CVS Value Pack Maximum Strength Severe Congestion & Cough Overnight Cold and Flu Clear and cool
CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH  OVERNIGHT COLD AND FLU CLEAR AND COOL
dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen and triprolidine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-967
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-967-121 in 1 CARTON; Type 0: Not a Combination Product03/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 180 mL
Part 21 BOTTLE 180 mL
Part 1 of 2
MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH 
dextromethorphan hbr, guaifenesin and phenylephrine hcl solution
Product Information
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
1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2020
Part 2 of 2
CVS OVERNIGHT COLD AND FLU CLEAR AND COOL 
acetaminophen, dextromethorphan hbr, phenylephrine hcl and triprolidine hcl solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
edetate disodium (UNII: 7FLD91C86K)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
propyl gallate (UNII: 8D4SNN7V92)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
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
1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2020
Labeler - CVS (062312574)

Revised: 4/2020
Document Id: d90ee70c-59df-4976-b66b-b8ece17f744a
Set id: d90ee70c-59df-4976-b66b-b8ece17f744a
Version: 1
Effective Time: 20200413
 
CVS