FDA Label for Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSES
- USES
- WARNINGS
- 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack 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)
Acetaminophen 1000 mg
Dextromethorphan HBr 30 mg
Acetaminophen 1000 mg
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
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
• temporarily reduces fever• 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• skin reddening• blisters• rash• 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:
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.
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.• 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• 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• 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 the blood thinning drug warfarin• taking sedatives or tranquilizers
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
• 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.• 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.
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
• do not use more than directed• measure the dose correctly using the enclosed dosing cup• adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist• do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor• children under 12 years of age: do not use• do not use more than directed• measure the dose correctly using the enclosed dosing cup• adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist• do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor• children under 12 years of age: do not use
Other Information
• each 30 mL contains: potassium 6 mg, sodium 32 mg• store at 20-25°C (68-77°F). Do not refrigerate.• each 30 mL contains: potassium 6 mg, sodium 32 mg• store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, light amber honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, light amber honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
Questions Or Comments?
call 1-800-328-5259
call 1-800-328-5259
Other Safety Information
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS: Learn about teen medicine abuse
www.StopMedicineAbuse.org
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
Made in Canada
Principal Display Panel
NDC 0067-8204-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
DAYTIME FORMULA
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Powerful fever fighting
formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
Honey & Elderberry Flavor
8.3 FL OZ (245.5mL)
NDC 0067-8205-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
NIGHTTIME
HELPS YOU REST
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Powerful fever fighting
formula that relieves:
/ Body ache
/ Headache
/ Sore throat pain
/ Cough
/ Runny nose
Honey & Elderberry Flavor
8.3 FL OZ (245.5mL)
NIGHTTIME
* Please review the disclaimer below.
