CVS DAYTIME AND NIGHTTIME VALUE PACK COLD AND FLU- acetaminophen, phenylephrine hydrochloride, and doxylamine succinate 
CVS PHARMACY

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CVS DayTime & NightTime Cold & Flu Combo pack

DayTime Cold & Flu

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

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 4 doses in 24 hours, which is the maximum daily amount for this product
taken 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 or pharmacist before use if you are 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

take only as directed
Only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hours

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

each 30 mL contains:

sodium 81 mg
store at room temperature
Do not refrigerate.

Inactive ingredients

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

NIGHTTIME COLD & FLU RELIEF

Active ingredients (in each caplet)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg

Purpose

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 doses in 24 hours, which is the maximum daily amount for this product
taken 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

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 & 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

take only as directed
Only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hours

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

each 30 mL contains: sodium 81 mg
Store at room temperature
Do not refrigerate

Inactive ingredients

Citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No.1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions?

1-866-467-2748

Distributed By:

PRINCIPAL DISPLAY PANEL - Kit Carton

**Compare to the active ingredients in Vicks®DayQuil™ Severe+ VapoCOOL™

NDC# 51316-156-24

DayTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Guaifenesin - Expectorant

Phenylephrine HCl – Nasal decongestant

For Relief of

Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Cough
Chest Congestion

*Compare to the active ingredients in Vicks®NyQuil™ Severe+ VapoCOOL™

NightTime

Cold & Flu

Relief

Acetaminophen – Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Phenylephrine HCl - Antihistamine

Phenylephrine HCl – Nasal decongestant

For Relief of

Minor Aches & Pains, Fever
Nasal Congestion & Sinus Pressure
Sneezing, Runny Nose
Cough

TWO BOTTLES, 12 FL OZ (354 mL) each; TOTAL 24 FL OZ (708 mL)

**This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks®Dayquil™ Severe+ VapoCOOL™ and Vicks® Nyquil™ Severe+ VapoCOOL™

CVS Daytime and NightTime Cold And Flu relief 708 mL
CVS DAYTIME AND NIGHTTIME VALUE PACK  COLD AND FLU
acetaminophen, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-156
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-156-241 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 354 mL
Part 21 BOTTLE 354 mL
Part 1 of 2
CVS DAYTIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:51316-412
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-412-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/10/2023
Part 2 of 2
CVS NIGHTTIME  COLD AND FLU
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide liquid
Product Information
Item Code (Source)NDC:51316-712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
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
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-712-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01003/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/10/2023
Labeler - CVS PHARMACY (062312574)

Revised: 11/2023
Document Id: 3eabf9a5-c05a-479b-9b66-ff90ff586578
Set id: 4c813cd5-2c97-4fc3-926c-1a0396551a31
Version: 3
Effective Time: 20231102
 
CVS PHARMACY