THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl 
Haleon US Holdings LLC

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Drug Facts

Theraflu Severe Cold Relief Daytime

Active ingredients (in each packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

Warnings

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

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

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
  • 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 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

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • 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

  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

call 1-855-328-5259

Theraflu Severe Cold Relief Nighttime

Active ingredients (in each packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Warnings

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

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

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.
  • with any other product containing diphenhydramine, even one used on the 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

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • 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

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • 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

  1. Age
  1. Dose
  1. adults and children 12 years of age and over
  1. one packet
  1. children under 12 years of age
  1. do not use

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

call 1-855-328-5259

Additional Information

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT

DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.

1-855-328-5259

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

©2022 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

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

Principal Display Panel

NDC 0067-6804-02

THERAFLU

SEVERE COLD RELIEF

COMBO PACK

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Nasal Decongestant

6 x NIGHTTIME

Acetaminophen Pain Reliever/Fever Reducer

Diphenhydramine HCl Antihistamine/Cough Suppressant

Phenylephrine HCl Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Sore throat / Cough / Fever

Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon

CM20326

Theraflu Severe Cold Relief Comb Pack 12 total packets

Principal Display Panel

THERAFLU

SEVERE COLD RELIEF

DAYTIME FORMULA

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Fever

Honey Lemon

6 PACKETS

62000000075408 – Front Carton

Theraflu Severe Cold Relief Daytime 6 packets

Principal Display Panel

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

HELPS YOU REST

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Runny nose

Fever

Honey Lemon

6 PACKETS

62000000075405 – Front Carton

Theraflu Severe Cold Relief Nightime 6 packets
THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6804
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6804-021 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product01/20/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 1422 mL
Part 26 PACKET 1422 mL
Part 1 of 2
THERAFLU   SEVERE COLD RELIEF DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
Product Information
Item Code (Source)NDC:0067-6802
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 237 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 237 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 237 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (HONEY LEMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6802-026 in 1 CARTON
1237 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/20/2023
Part 2 of 2
THERAFLU   SEVERE COLD RELIEF NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
Product Information
Item Code (Source)NDC:0067-6803
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 237 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 237 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 237 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (HONEY LEMON FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6803-026 in 1 CARTON
1237 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/20/2023
Labeler - Haleon US Holdings LLC (079944263)

Revised: 1/2024
Document Id: 103fee61-db67-5ad2-e063-6394a90a572a
Set id: e5ef7b85-feee-44a7-bd0e-ed91352c7434
Version: 2
Effective Time: 20240131
 
Haleon US Holdings LLC