FDA Label for Antiflu Des Cough And Flu
View Indications, Usage & Precautions
Antiflu Des Cough And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Productos Farmaceuticos, S.a. De C.v.. 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
Acetaminophen 325 mg
Phenylephrine HCl 10 mg
Chlorpheniramine Maleate 4 mg
Purpose
Pain reliever/fever reducer
Nasal decongestant
Antihistamine
Uses
Temporarily relieves common cold and flu symptoms: ▪sore throat ▪headache ▪minor aches and pains ▪fever ▪stuffy/runny nose and sneezing
Warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪More than 4,000 mg in 24 hours, which is the maximum daily amount ▪ With other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms can include▪ skin reddening ▪ blisters ▪ rash ▪ hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock. If a skin or any allergic reaction occurs, stop use and seek medical attention right away.
Sore throat warning: Severe or persistent sore throat lasting more than 2 days or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. 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. If you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if you have taken these products 2 weeks previously. If you do not know if your prescription drug contains an MAOI, ask a Doctor before taking this product
Ask A Doctor Before Use If You Have
▪ Liver disease ▪ Heart disease ▪ High blood pressure ▪ Thyroid disease ▪ Diabetes ▪Glaucoma ▪ Breathing problem due to any given cause (asthma, chronic bronchitis or emphysema) ▪ Trouble urinating due to an enlarged prostate gland
Ask A Doctor Before Use If You Are
▪Taking sedatives or tranquilizers ▪Taking the blood thinning drug warfarin
When Using This Product
▪ Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a Doctor. ▪ Do not mix with alcohol, sedatives and tranquilizers as they may increase drowsiness ▪ Driving a motor vehicle or operating machinery could be affected ▪ Excitability may occur especially in children(12-18 y) ▪ if symptoms do not improve within 7 days or are accompanied by fever, consult a Doctor
Stop Use And Ask A Doctor If
▪ Pain, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ▪ Fever gets worse or last more than 3 days ▪ Redness or swelling is present ▪ New symptoms occur
Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use .
As with all medical products keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours. ▪ Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use
Other Information
Do not store above 77°F(25°C) and in a dry place
Inactive Ingredients
Colloidal Silcon Dioxide, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Lactose Monohdyrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Shellac, Synthetic Iron Oxide, Titanium Dioxide
Questions And Comments?
You may report any side effects to 1-305-677-0850 Monday through Sunday 24 hrs
Package Label
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