CVS DAYTIME AND NIGHTTIME SEVERE COLD AND FLU RELIEF BUNDLE- acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl 
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 Daytime and Nighttime Severe Cold & Flu Relief

CVS Daytime Severe Cold & Flu Relief

Active Ingredients (in each Single-Use Vial, 15mL)

Acetaminophen USP, 325mg

Dextromethorphan HBr, USP, 10mg

Guaifenesin, USP 200mg

Phenylephrine HCl, USP, 5mg

Purposes

Pain Reliever/ Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Uses

Temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ 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 8 vials in 24 hours which is the maximum daily amount for this product ■ 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Ask a doctor before use if you have

■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease

■ diabetes ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you

taking the blood thinning drug warfarin.

When using this product

do not use more than directed.

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless ■ 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 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. 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

■ empty each Single-Use Vial of all liquid when dosing.

■ use the chart below to confirm the dose

Age (Years)Dose
Children under 4 years oldDo not use
Children 4 to under 12 years oldAsk a doctor
Adults and children 12 years and over

2 Single Use Vials (15 mL) Every 4 hours while symptoms last

Do not exceed 8 Single Use Vials in 24 hours

Other information

■ each single-use vial (15 mL) contains 16mg of sodium

■ Store at 20-25oC (68-77oF)

■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.

Inactive Ingredients

citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum

Question or Comments?

1-800-719-9260

CVS Nighttime Severe Cold & Flu Relief

Active Ingredients (in each Single-Use Vial, 30mL)

Acetaminophen USP, 650mg

Dextromethorphan HBr, USP, 20mg

Doxylamine succinate, USP, 12.5mg

Phenylephrine HCl, USP, 10mg

Purposes

Pain Reliever/ Fever reducer

Cough suppressant

Antihistamine

Nasal Decongestant

Uses

temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 vials in 24 hours which is the maximum daily amount for this product ■ 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

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 ■ to make a child sleep

Ask a doctor before use if you have

■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease

■ diabetes ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin

When using this product

■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless ■ 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 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. 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

■ empty each Single-Use Vial of all liquid when dosing.

■ use the chart below to confirm the dose

Age (Years)Dose
Children under 4 years oldDo not use
Children 4 to under 12 years oldAsk a doctor
Adults and children 12 years and over

1 Single Use Vial (30mL) every 4 hours while symptoms last

Do not exceed 4 Single Use Vials in 24 hours

Other information

■ each single-use vial (30 mL) contains 31mg of sodium

■ Store at 20-25oC (68-77oF)

■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.

Inactive Ingredients

citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum

Question or Comments?

1-800-719-9260

Package

Package

CVS DAYTIME AND NIGHTTIME SEVERE COLD AND FLU RELIEF BUNDLE 
acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-495
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-495-161 in 1 BOX06/29/202106/30/2023
11 in 1 BOX
11 in 1 BOX; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL 15 mL  in 8 
Part 21 VIAL 30 mL  in 8 
Part 1 of 2
CVS HEALTH DAYTIME SEVERE COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Item Code (Source)NDC:69842-499
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
MALTITOL (UNII: D65DG142WK)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-499-088 in 1 BOX
115 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/2021
Part 2 of 2
CVS NIGHTTIME SEVERE COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl solution
Product Information
Item Code (Source)NDC:69842-497
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
MALTITOL (UNII: D65DG142WK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-497-088 in 1 BOX
130 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/202106/30/2023
Labeler - CVS Pharmacy (062312574)

Revised: 12/2022
 
CVS Pharmacy