TherafluSevere Cold Relief
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Label updated
- 2024-10-14
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · DIPHENHYDRAMINE HYDROCHLORIDE · GUAIFENESIN
Active ingredients (in each 30 mL) (Daytime)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Purposes (Daytime)
Pain reliever/Fever reducer
Cough suppressant
Expectorant
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 fever -
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 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.
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 (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 |
Other information (Daytime)
-
• each 30 mL contains: potassium 30 mg, sodium 13 mg -
• store at controlled room temperature 20°-25°C (68°-77°F)
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, sodium benzoate, sodium citrate
Questions or comments? (Daytime)
1-855-328-5259
Active ingredients (in each 30 mL) (Nighttime)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Purposes (Nighttime)
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
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 fever -
• cough due to minor throat and bronchial irritation
-
-
• temporarily reduces fever
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 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 lastsThese 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 (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 (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 |
Other information (Nighttime)
-
• each 30 mL contains: potassium 30 mg, sodium 13 mg -
• store at controlled room temperature 20°-25°C (68°-77°F)
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, sodium benzoate, sodium citrate
Questions or comments? (Nighttime)
1-855-328-5259
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 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:
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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.
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 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
[Image in the official label — see DailyMed source]
DailyMed Set ID: b01cc9f5-53f2-40d8-acf1-6de180b3d0bf · Version 1
NDC: 0067-0107