DailyMed - THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

NDC Code(s): 0067-0104-08, 0067-0105-08, 0067-0107-01
Packager: Haleon US Holdings LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated October 14, 2024

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Active ingredients (in each 30 mL) (Daytime)
Acetaminophen 650 mg - Dextromethorphan HBr 20 mg - Guaifenesin 400 mg

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg
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Purposes (Daytime)
Pain reliever/Fever reducer - Cough suppressant - Expectorant

Pain reliever/Fever reducer

Cough suppressant

Expectorant
Close
Uses (Daytime)
• temporarily relieves these symptoms due to a cold: • minor aches and pains - • minor sore throat pain - • headache - • cough due to minor throat and bronchial irritation - • temporarily reduces ...

•

temporarily relieves these symptoms due to a cold:

•

minor aches and pains

•

minor sore throat pain

•

headache

•

cough due to minor throat and bronchial irritation

•

temporarily reduces fever

•

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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Warnings (Daytime)
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 ...

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

•

cough that occurs with too much phlegm (mucus)

•

a breathing problem such as emphysema or chronic bronchitis

•

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

•

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•

fever gets worse or lasts more than 3 days

•

redness or swelling is present

•

new symptoms occur

•

pain or cough 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.

Close
Directions (Daytime)
• do not use more than directed - • measure the dose correctly using the enclosed dosing cup - • take every 4 hours in dosing cup provided, while symptoms persist - • do not take more than 5 doses ...

•

do not use more than directed

•

measure the dose correctly using the enclosed dosing cup

•

take every 4 hours in dosing cup provided, while symptoms persist

•

do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age

Dose

adults and children 12 years of age and over

30 mL

children under 12 years of age

do not use

Close
Other information (Daytime)
• each 30 mL contains: potassium 30 mg, sodium 13 mg - • store at controlled room temperature 20°-25°C (68°-77°F)

•

each 30 mL contains: potassium 30 mg, sodium 13 mg

•

store at controlled room temperature 20°-25°C (68°-77°F)

Close
Inactive ingredients (Daytime)
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water ...

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Close
Questions or comments? (Daytime)
1-855-328-5259

1-855-328-5259
Close
Active ingredients (in each 30 mL) (Nighttime)
Acetaminophen 650 mg - Diphenhydramine HCl 25 mg

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg
Close
Purposes (Nighttime)
Pain reliever/Fever reducer - Antihistamine/Cough suppressant

Pain reliever/Fever reducer

Antihistamine/Cough suppressant
Close
Uses (Nighttime)
• temporarily relieves these symptoms due to a cold: • minor aches and pains - • minor sore throat pain - • headache - • runny nose - • sneezing - • itchy nose or throat - • itchy, watery eyes due to hay ...

•

temporarily relieves these symptoms due to a cold:

•

minor aches and pains

•

minor sore throat pain

•

headache

•

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

Close
Warnings (Nighttime)
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 ...

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.

•

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

•

glaucoma

•

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 sedatives or tranquilizers

•

taking the blood thinning drug warfarin

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

•

fever gets worse or lasts more than 3 days

•

redness or swelling is present

•

new symptoms occur

•

pain or cough 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.

Close
Directions (Nighttime)
• do not use more than directed - • measure the dose correctly using the enclosed dosing cup - • take every 4 hours in dosing cup provided, while symptoms persist - • do not take more than 5 doses ...

•

do not use more than directed

•

measure the dose correctly using the enclosed dosing cup

•

take every 4 hours in dosing cup provided, while symptoms persist

•

do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age

Dose

adults and children 12 years of age and over

30 mL

children under 12 years of age

do not use

Close
Other information (Nighttime)
• each 30 mL contains: potassium 30 mg, sodium 13 mg - • store at controlled room temperature 20°-25°C (68°-77°F)

•

each 30 mL contains: potassium 30 mg, sodium 13 mg

•

store at controlled room temperature 20°-25°C (68°-77°F)

Close
Inactive ingredients (Nighttime)
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water ...

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate
Close
Questions or comments? (Nighttime)
1-855-328-5259

1-855-328-5259
Close
Additional Information
DO NOT TAKE THE DAYTIME AND 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 NIGHTTIME PRODUCT SOONER THAN 4 HOURS ...

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

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR 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 NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

*Temporarily controls cough to help you rest. This is not a sleep aid.
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Principal Display Panel (Day/Night Combination)
MULTI-SYMPTOM COLD RELIEF - NEW FORMULA - VALUE PACK - DAYTIME FORMULA - SEVERE COLD RELIEF - MULTI-SYMPTOM COLD RELIEF - NEW FORMULA - THERAFLU - SEVERE COLD RELIEF + CHEST ...

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

VALUE PACK

DAYTIME FORMULA

SEVERE COLD RELIEF

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF + CHEST CONGESTION

ACETAMINOPHEN

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough suppressant

Guaifenesin / Expectorant

DAYTIME FORMULA

Powerful formula that relieves:

/ Chest congestion

/ Thins and loosens mucus

/ Head and body ache

/ Fever

/ Cough

/ Sore throat pain

8.3 FL OZ (245.5 mL) Berry Flavor

SEVERE COLD RELIEF

HELPS YOU REST*

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF NIGHTTIME

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

HELPS YOU REST*

Powerful formula that relieves:

/ Cough

/ Sore throat pain

/ Head and body ache

/ Fever

/ Runny nose

/ Sneezing

8.3 FL OZ (245.5 mL) Berry Flavor

2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)

USE ONLY AS DIRECTED

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INGREDIENTS AND APPEARANCE

Product Information

THERAFLU SEVERE COLD RELIEF acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-0107

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0107-01	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	02/01/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	0 BOTTLE	1 mL
Part 2	0 BOTTLE	1 mL

Part 1 of 2

THERAFLU SEVERE COLD RELIEF CHEST CONGESTION DAYTIME acetaminophen, dextromethorphan hbr, guaifenesin syrup

Product Information
Item Code (Source)	NDC:0067-0104
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0104-08	245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/01/2023

Part 2 of 2

THERAFLU SEVERE COLD RELIEF NIGHTTIME acetaminophen, diphenhydramine hcl syrup

Product Information
Item Code (Source)	NDC:0067-0105
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0105-08	245.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	02/01/2024

Labeler - Haleon US Holdings LLC (079944263)

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	RxCUI	RxNorm NAME	RxTTY
1	1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	PSN
2	1042695	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution	SCD
3	1042695	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution	SY
4	1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	SY
5	1042695	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral Solution	SY
6	1294607	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution	PSN
7	1294607	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution	SCD
8	1294607	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral Solution	SY
9	1294607	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral Solution	SY
10	2695452	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution) Pack	PSN
11	2695452	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution) } Pack	GPCK
12	2695452	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 per 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG per 30 mL Oral Solution) Pack	SY

Label: THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Age	Dose
adults and children 12 years of age and over	30 mL
children under 12 years of age	do not use

	NDC
1	0067-0104-08
2	0067-0105-08
3	0067-0107-01

Label: THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

Number of versions: 1

THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

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THERAFLU SEVERE COLD RELIEF- acetaminophen, dextromethorphan hbr, diphenphydramine hcl, guaifenesin kit

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