COLDTAC Plus (acetaminophen 325 mg phenylephrine hydrochloride 5 mg dextromethorphan hydrobromide 15 mg) Dailymed

Generic: acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

IMPRINT: A15 SHAPE: oval
COLOR: white SCORE: 2

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Drug Facts

Active Ingredients (in each tablet)

Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer

Guaifenesin USP 200mg..............................................................Expectorant

Phenylephrine HCL USP 5mg........................................................Decongestant

Dextromethorphan HBr USP 15mg................................................Antitussive

Purpose

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Uses

Temporarily

Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Relieves sinus congestion and pressure, helps decongest sinus openings and passages

Restores freer breathing

Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive

Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps

Warnings: Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

More than 8 tablets in 24 hours

With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure

3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symproms may include: skin reddening, bulers, rash if a skin reaction occurs, stop use and seek medical help right away.

Warning:

a persistent cough may be sing of a serious condition

Do not:

use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and cold cause serious health concerns.

use more than the recommended dose

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

when using this product do not exceed recommended dose

if you are now taking a presription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product

take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop Use And Ask A Doctor If:

symptoms do not improve, pain or fever persists or gets worse, new symptoms occur, redness or swelling is present, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Ask A Doctor Before Use If You Have:

heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, liver disease

Ask A Doctor Or Pharmacist If You Are

taking the blood thinning drug warfarin.

Do Not Exceed Recommended Dosage

if nervousness, dizziness, or sleeplessness occur, discontinue use consult a doctor.

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:

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Other Inforamtion:

Tamper evident. Do not use if packet is torn, cut or opened

Store at controlled room temperature 15° to 30°C (59° to 86°F)

Avoid excessive heat and humidity

Inactive Ingredients

Corn Starch, Crospovidone, Microcrystalline cellulose, Povidone k30, Silicon dioxide, Stearic acid, Talc, Water

Questions Or Comments?

Call: 619-600-5632 (Mon-Fri 9am - 5pm EST)

Coldtac Plus 2 Tablets In A Pouch - 12 Tablets

NDC 69729-143-06

Coldtac Plus 2 Tablets In A Pouch - 144 Tablets

NDC 69729-143-72

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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