FDA Label for Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant Nighttime
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?
- ADDITIONAL INFORMATION
- PRINCIPAL DISPLAY PANEL
Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant Nighttime 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
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Pseudoephedrine HCl 60 mg
Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- minor sore throat pain
- runny nose
- cough due to minor throat and bronchial irritation
- nasal and sinus congestion
- 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
- If a skin reaction occurs, stop use and seek medical help right away.
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.
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
- 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 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
- nervousness, dizziness, or sleeplessness occurs
- pain, cough or nasal congestion 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
- 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
- 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
- Age
- Dose
- adults and children 12 years of age and over
- 30 mL every 6 hours
- children under 12 years of age
- do not use
Other Information
- each 30 mL contains: sodium 26 mg
- store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.
Inactive Ingredients
alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Questions Or Comments?
1-855-328-5259
Additional Information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING.
Distributed by: Haleon
Warren, NJ 07059
Made in Canada
©2024 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
Principal Display Panel
MULTI-SYMPTOM RELIEF NEWHALEON
THERAFLU-D
FLU RELIEF
MAX STRENGTH*
+ NASAL DECONGESTANT
NIGHTTIME
Acetaminophen
Pain Reliever/Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
Pseudoephedrine HCI
Nasal Decongestant
Fast, Powerful Multi-Symptomrelief of:
/ Fever
/ Nasal congestion
/ Sinus Pressure
/ Head & Body Ache
/ Sore Throat Pain
/ Cough
/ Runny Nose
/ Sneezing
Cherry Flavor
8.0 FL OZ (237 mL)
62000000209276 Carton Front
* Please review the disclaimer below.