MULTI SYMPTOM FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK- acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr 
CVS PHARMACY

----------

Theraflu Flu Relief Max Strength Combo Pack Drug Facts

Theraflu Flu Relief Max Strength* Daytime Powder

Active ingredients (in each packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Uses

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

Warnings

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

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

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 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
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

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

pain 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
 
Age
 
Dose
 
adults and children 12 years of age and over
 
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 the 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

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

Inactive ingredients

anhydrous citric acid, caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose.

Questions or comments?

1-866-467-2748

Theraflu Flu Relief Max Strength Nighttime* Powder

Drug Facts

Active ingredients (in each packet)

Acetaminophen 1000 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan HBr 30 mg

Purposes

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

temporarily relieves these symptoms due to a common cold:
headache
minor aches and pains
cough due to minor throat and bronchial irritation
minor sore throat pain
runny nose
temporarily reduces fever

Warnings

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

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

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 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 a MAO, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

liver disease
glaucoma
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

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

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

pain 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
 
Age
 
Dose
 
adults and children 12 years of age and over
 
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

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

Inactive ingredients

anhydrous citric acid, caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose.

Questions or comments?

1-866-467-2748

Other Safety Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

Distributed by:

Principal Display Panel

*Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Daytime & Nighttime.

NDC 51316-559-06

FLU RELIEF

MAX STRENGTH**

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

6 x NIGHTTIME

Acetaminophen Pain Reliever/Fever Reducer

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Cough Suppressant

Hot liquid therapy that relieves:

Fever
Body ache
Headache
Sore throat pain
Cough
Runny nose (Nighttime only)

Free from synthetic dyes

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon

Natural & Artificial Flavored

 Flu Relief DayTime and NightTime Powder 12ct
MULTI SYMPTOM FLU RELIEF MAX STRENGTH  DAYTIME NIGHTTIME COMBO PACK
acetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-559
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-559-061 in 1 CARTON; Type 1: Convenience Kit of Co-Package04/21/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CARTON
Part 21 CARTON
Part 1 of 2
MS FLU RELIEF MAX STRENGTH  DAYTIME
acetaminophen, dextromethorphan hbr powder
Product Information
Item Code (Source)NDC:51316-558
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorWHITE (to off white, yellow, beige, and brown color) Score    
ShapeSize
FlavorHONEY (Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-558-066 in 1 CARTON; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/21/2023
Part 2 of 2
MS FLU RELIEF MAX STRENGTH  NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr powder
Product Information
Item Code (Source)NDC:51316-560
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorWHITE (white to off-white, yellow, beige, and brown color) Score    
ShapeSize
FlavorHONEY (lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-560-066 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/21/2023
Labeler - CVS PHARMACY (062312574)

Revised: 3/2024
Document Id: e8e19e41-fe16-40fb-970f-1a2369477e07
Set id: 5151127a-4d09-413a-a08b-f76fb77e1188
Version: 2
Effective Time: 20240325
 
CVS PHARMACY