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  5. Label Information: Cold Multi-symptom Day-time

FDA Label for Cold Multi-symptom Day-time

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?

Cold Multi-symptom Day-time Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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 Ingredient



Acetaminophen 325 mg
Guaifenesin 200 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg


Purpose



Analgesic/Antipyretic
Expectorant
Cough suppressant
Decongestant


Uses



for the temporary relief of the following cold/flu symptoms: •minor aches and pains • headache • sore throat •nasal congestion •cough •impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever


Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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


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 products containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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 drugs. 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■ 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 taking sedatives or tranquilizers


When Using This Product



do not use exceed recommended dosage


Stop Use And Ask A Doctor If



■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts for more than 7 days ■ fever gets worse or lasts for 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, contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms


Directions



Adults and children 12 years and over: take 2 caplets every 4 hours ■ do not take more than a total of 12 caplets in 24 hours
Children under 12 years: Do not use this adult product in children under 12 years of age. This will provide more than recommended dose (overdose) and may cause liver damage


Other Information



store at room temperature 59°-86° F (15°-30° C) do not use if blister is torn or open


Inactive Ingredients



corn starch, croscarmellose sodium, crospovidone, FD&C Yellow #10, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide


Questions Or Comments?



Call toll free 1-888-952-0050


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