NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin 
CVS Pharmacy

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Non Drowsy Severe Daytime and Severe Nighttime Cold and Flu Relief

Drug Facts

Non Drowsy Severe Daytime Cold and Flu Relief

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

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 4 doses 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 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.

Overdose warning

Taking more than directed can cause serious health problems. 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 - see Overdose warning
■ do not exceed 4 doses per 24 hours

adults & children 12 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other information

■ store at room temperature

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Drug Facts 

Severe Nighttime Cold and Flu Relief

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

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 thr

Warnings

Liver warning This product contains acetaminophen. Severe liverdamage may occur if you take
■ more than 4 doses in 24 hours, which is the maximum dailyamount 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 chronic cough that lasts or 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.

Overdose warning

Taking more than directed can cause serious health problems. 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 - see Overdose warning
■ do not exceed 4 doses per 24 hours

adults & children 12 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Other information

store at room temperature

Inactive ingredients

D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide

Questions or comments?

Call toll free: 1-888-333-9792

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NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-106
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-106-241 in 1 CARTON; Type 1: Convenience Kit of Co-Package11/10/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BLISTER PACK
Part 20 BLISTER PACK
Part 1 of 2
NON DROWSY SEVERE DAYTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:51316-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize20mm
FlavorImprint Code 341;A13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/10/2022
Part 2 of 2
SEVERE NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Item Code (Source)NDC:51316-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code 116;A07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/10/2022
Labeler - CVS Pharmacy (062312574)

Revised: 12/2023
Document Id: 0bf0899b-c17e-05cf-e063-6294a90a3cfe
Set id: 8624a453-42bd-4876-9f7e-0cfc618a0984
Version: 3
Effective Time: 20231207
 
CVS Pharmacy