FDA Label for Theraflu Severe Cold Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML) (DAYTIME)
- PURPOSES (DAYTIME)
- USES (DAYTIME)
- WARNINGS (DAYTIME)
- 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.
- DIRECTIONS (DAYTIME)
- OTHER INFORMATION (DAYTIME)
- INACTIVE INGREDIENTS (DAYTIME)
- QUESTIONS OR COMMENTS? (DAYTIME)
- ACTIVE INGREDIENTS (IN EACH 30 ML) (NIGHTTIME)
- PURPOSES (NIGHTTIME)
- USES (NIGHTTIME)
- WARNINGS (NIGHTTIME)
- WHEN USING THIS PRODUCT
- DIRECTIONS (NIGHTTIME)
- OTHER INFORMATION (NIGHTTIME)
- INACTIVE INGREDIENTS (NIGHTTIME)
- QUESTIONS OR COMMENTS? (NIGHTTIME)
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL (DAY/NIGHT COMBINATION)
Theraflu Severe Cold Relief Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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• skin reddening• blisters• rash
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.• 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• 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• 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 the blood thinning drug warfarin• taking sedatives or tranquilizers• 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• 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.
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
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• skin reddening• blisters• rash
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.
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
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
* Please review the disclaimer below.
