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  5. Label Information: Leader Tussin Cf

FDA Label for Leader Tussin Cf

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 20 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. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Leader Tussin Cf Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 20 Ml)



Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg


Purposes



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • •temporarily relieves these symptoms occurring with a cold or flu:
  • •cough due to minor throat and bronchial irritation
  • •nasal congestion
  • •sinus congestion and pressure
  • •minor aches and pains
  • •sore throat
  • •headache
  • •temporarily reduces fever
  • •helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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 fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Do Not Use



  • •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.
  • •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 have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have



  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough 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

When Using This Product



do not use more than directed


Stop Use And Ask A Doctor If



  • •you get nervous, dizzy or sleepless
  • •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.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 take more than 5 doses in any 24-hour period
  • •do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL = milliliter
  • •this adult product is not intended for use in children under 12 years of age

    • age

    dose

    adults and children

    12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use


Other Information



  • •each 20 mL contains: sodium 15 mg
  • •store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients



anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Adult | Maximum Strength

Tussin CF

Severe Multi-Symptom Cough Cold + Flu CF

Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

Ages 12 Years and Over

Relieves:

Cough, Sore Throat, Body Aches, Fever, Nasal Congestion, Chest Congestion

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD + FLU active ingredients

Non-Drowsy

100% Money Back Guarantee

4 FL OZ (118mL)

7c1-e9-tussin.jpg - 7c1 e9 tussin

7c1-e9-tussin.jpg - 7c1 e9 tussin


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