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  5. Label Information: Theraflu Severe Cold Relief Chest Congestion Daytime

FDA Label for Theraflu Severe Cold Relief Chest Congestion Daytime

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. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. GENERIC SECTION
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Theraflu Severe Cold Relief Chest Congestion Daytime 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 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Purposes



Pain reliever/Fever reducer

Cough suppressant

Expectorant


Uses



  • •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



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 a 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



  • •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



  • •each 30 mL contains: potassium 30 mg, sodium 13 mg
  • •store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients



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?



1-855-328-5259


Generic Section



Distributed by: Haleon, Warren, NJ 07059. Made in Canada

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

©2023 Haleon group of companies or its licensor. Pat. Info www.productpats.com 62000000207727

PEEL BACK HERE

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


Package/Label Principal Display Panel



MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE

COLD RELIEF

+ CHEST CONFESTION

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

62000000207725

Theraflu SCRCC Day 8oz - TherafluSCRCCDay8oz.JPG

Theraflu SCRCC Day 8oz - TherafluSCRCCDay8oz.JPG


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