SEVERE COLD PLUS FLU DAYTIME NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate 
CVS Pharmacy,Inc.

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 Health Severe Cold & Flu Daytime and Nighttime


SEVERE COLD + FLU DAYTIME

Drug Facts

Active ingredients (in each packet)Purposes

Acetaminophen 500 mg

Pain reliever/fever reducer

Dextromethorphan hydrobromide 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine hydrochloride 10 mg

Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold or flu:
minor aches and pains
headache
sore throat
cough
nasal congestion
sinus congestion and pressure
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 packets 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 or severe allergic reactions. Symptoms may include:
Skin reddening
Blisters

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.
if you have ever had an allergic reaction to this product or any of its ingredients
in children under 12 years of age

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough with excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

pain, cough, or nasal congestion 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.
nervousness, dizziness, or sleeplessness occurs

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 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 or symptoms.

Directions

do not take more than the recommended dose
take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

Other information

each packet contains: potassium 6 mg
store at room temperature

Inactive ingredients

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

Questions or comments?

1-866-467-2748

SEVERE COLD + FLU NIGHTTIME

Drug Facts

Active ingredients (in each packet)Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan hydrobromide 20 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Phenylephrine hydrochloride 10 mg

Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold or flu:
headache
minor aches and pains
cough
sore throat
nasal congestion
sinus congestion and pressure
runny nose
sneezing
temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 5 packets 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

Is a skin or general allergic 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 to sedate children.

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.
if you have ever had an allergic reaction to this product or any of its ingredients
in children under 12 years of age

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough with excessive phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

pain, cough, or nasal congestion 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.
nervousness, dizziness, or sleeplessness occurs

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 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 or symptoms.

Directions

do not take more than the recommended dose
take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

Other information

each packet contains: potassium 6 mg
store at room temperature

Inactive ingredients

anhydrous citric acid, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose, yellow#6

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL-

Compare to Alka-Seltzer PLUS® Severe Cold +Flu Day and Night Active Ingredients*

DAYTIME

SEVERE COLD & FLU

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant

Relieves:
• Nasal Congestion • Headache
• Sore Throat • Body Ache • Cough
• Mucus • Chest Congestion • Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

NIGHTTIME

Severe Cold & Flu

Acetaminophen / Pain reliever-fever reducer

Dextromethorphan HBr / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCl / Nasal decongestant

Relieves:

• Nasal Congestion • Headache
• Sore Throat • Body Ache
• Cough • Runny Nose • Fever

Honey Lemon Flavor

Naturally and Artificially Flavored

TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL POUCH IS TORN OR OPEN

DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

6 DAY PACKETS + 6 NIGHT PACKETS
12 TOTAL

Distributed by: CVS Pharmacy, Inc.

One CVS Drive Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Money Back Guarantee

*These products is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Alka-Seltzer plus® Severe Cold +Flu Day and Night.

Severe Cold Plus Flu Daytime and Nighttime Honey Lemon Flavor
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-546
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-546-121 in 1 CARTON; Type 0: Not a Combination Product07/14/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CARTON
Part 21 CARTON
Part 1 of 2
SEVERE COLD PLUS FLU DAYTIME 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/2017
Part 2 of 2
SEVERE COLD PLUS FLU NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/2017
Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 9/2023
Document Id: a6f0a9bc-1b9d-476f-8292-9e12d32d1db2
Set id: 6cb1d08b-e544-4084-b9ed-1e0d99a709c8
Version: 6
Effective Time: 20230912
 
CVS Pharmacy,Inc.