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  5. Label Information: Theraflu Flu Relief Max Strength Nighttime

FDA Label for Theraflu Flu Relief Max Strength Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 30 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. ADDITIONAL INFORMATION
    17. PRINCIPAL DISPLAY PANEL

Theraflu Flu Relief Max Strength 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


Purposes



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

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

    • 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
  • •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

When Using This Product



  • •do not exceed recommended dosage.

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.
  •  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

Other Information



  • •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


Questions Or Comments?



1-855-328-5259


Additional Information



DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

LIFT HERE

*Maximum Strength per 6 hour dose.

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Dist. by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

Made in Canada

©2020 GSK group of companies or its licensor.


Principal Display Panel



NDC 0067-8205-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

NIGHTTIME

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 (245.5 mL)

1001488 Front Bottle Label


* Please review the disclaimer below.