THERAFLU RELIEF MAX STRENGTH NIGHTTIME- acetaminophen, chlorpheniramine maleate and dextromethophan hbr powder, for solution 
CVS PHARMACY

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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Theraflu Nighttime Flu Relief Max Strength Drug Facts

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

Principal Display Panel

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

NDC 51316-549-06

Nighttime

Flu Relief

MAX STRENGTH**

Acetaminophen Pain Reliever/Fever Reducer

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Cough Suppressant

Honey Lemon

Natural & Artificial Flavored

1 SINGLE DOSE

TO OPEN: CUT ALONG DOTTED LINE WITH SCISSORS DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime.

**Maximum Strength per 6 hours dose

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

 Flu Relief Nighttime Powder
THERAFLU RELIEF MAX STRENGTH  NIGHTTIME
acetaminophen, chlorpheniramine maleate and dextromethophan hbr powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-549
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
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 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:51316-549-061 in 1 PACKET; Type 0: Not a Combination Product04/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/17/2023
Labeler - CVS PHARMACY (062312574)

Revised: 5/2023
Document Id: 4b567234-1da9-4e10-a427-877eea2be1c1
Set id: 4b567234-1da9-4e10-a427-877eea2be1c1
Version: 1
Effective Time: 20230504
 
CVS PHARMACY