MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl 
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 Multi Symptom Severe Cold and Nighttime Severe Cold and Cough Value Pack

Active ingredients (in each packet) – Multi Symptom Severe Cold

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Active ingredients (in each packet) - Nighttime Severe Cold and Cough

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold and Cough

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses - Multi Symptom Severe Cold

temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
cough due to minor throat and bronchial irritation
temporarily reduces fever

Uses - Nighttime Severe Cold and Cough

temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

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

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 - Multi Symptom Severe Cold

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Do not use - Nighttime Severe Cold and Cough

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
with any other product containing diphenhydramine, even one used on skin
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 - Multi Symptom Severe Cold

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor before use if you have - Nighttime Severe Cold and Cough

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a sodium restricted diet
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are - Multi Symptom Severe Cold

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product - Multi Symptom Severe Cold

do not exceed recommended dosage

When using this product - Nighttime Severe Cold and Cough

do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
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 – Multi Symptom Severe Cold /Nighttime Severe Cold and Cough

nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
symptoms do not get better or worsen
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Multi Symptom Severe Cold

do not use more than directed
take every 4 hours, while symptoms persist; Do not to take 6 packets in 24 hours or as directed by a doctor
 
Age
 
Dose
 
Adults and children 12 years of age
 
One packet
 
Children under 12 years of age
 
Do not use

Directions Nighttime Severe Cold and Cough

do not use more than directed
take every 4 hours while symptoms persist;; not to exceed 5 packets in 24 hours or as directed by a doctor
 
Age
 
Dose
 
Adults and children 12 years of age
 
One packet
 
Children under 12 years of age
 
Do not use
Dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes
If using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Other information - Multi Symptom Severe Cold

each packet contains: potassium 6 mg
store at controlled room temperature. Protect from excessive heat and moisture.

Other information - Nighttime Severe Cold and Cough

each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients - Multi Symptom Severe Cold

anhydrous citric acid, caramel, flavors, maltodextrin, potassium citrate, silica, sucralose, sucrose

Inactive ingredients - Nighttime Severe Cold and Cough

citric acid, FD&C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose.

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL

Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold* & Theraflu® Nighttime Severe Cold & Cough*

Multi Symptom

Severe Cold

ACETAMINOPHEN - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever

Green Tea & Honey Lemon Flavors

6 PACKETS

NIGHTTIME

Severe Cold & Cough

ACETAMINOPHEN - Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl – Antihistamine; Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever
Runny nose
Sneezing

Honey Lemon Flavor Infused with Chamomile &White Tea Flavors

6 PACKETS

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 are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold and Theraflu® Nighttime Severe Cold & Cough.

CVS Health Multi symptom severe cold and cough relief
MULTI SYMPTOM SEVERE COLD AND NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-768
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-768-121 in 1 CARTON; Type 0: Not a Combination Product09/21/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CARTON
Part 21 CARTON
Part 1 of 2
CVS HEALTH MULTI SYMPTOM SEVERE COLD  MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
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 finalpart34107/21/2015
Part 2 of 2
CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD  NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
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 finalpart34108/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/21/2015
Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 9/2023
Document Id: 3905737f-509e-419a-9933-c49ca8c93d77
Set id: 91063edd-1e7e-41e9-8412-b14ef3749018
Version: 7
Effective Time: 20230912
 
CVS Pharmacy,Inc.