FDA Label for Leader Daytime Severe Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- 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?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Leader Daytime Severe Cold And Flu 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 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• minor aches and pains• headache• fever• sore throat• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage• 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
• adult takes more than 4,000 mg of acetaminophen in 24 hours• child takes more than 5 doses in 24 hours• taken with other drugs containing acetaminophen• adult has 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:
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
• 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.• 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• thyroid disease• diabetes• high blood pressure• 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, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)• 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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• take only as directed – see Overdose warning• only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 15 mL contains: sodium 6 mg• store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Maximum Strength | Non-Drowsy
Daytime Severe Cold & Flu
Acetaminophen | Dextromethorphan HBr
Guaifenesin | Phenylephrine HCl
Pain Reliever / Fever Reducer
Cough Suppressant | Expectorant
Nasal Decongestant
Original Flavor
Relief of:
Aches, Fever, Cough, Sore Throat, Nasal Congestion, Chest Congestion
Alcohol-Free
COMPARE TO VICKS® DAYQUIL® SEVERE active ingredients
SEE NEW WARNINGS
8 FL OZ (237 mL)
* Please review the disclaimer below.