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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. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reactio 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 product 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 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, ask a doctor or pharmacist before taking this product.
  • for more than 7 days for pain and 3 days for fever, unless directed by a doctor

Ask A Doctor Before Use


if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema

Ask A Doctor Or Pharmacist


before use if you are
  • taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • new symptoms occur
  • redness or swelling is present
  • pain or fever persists or gets worse
  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 accidental 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:

  • do not exceed recommended dosage
  • adults and children 12 years of age and over:

take 2 tablets every 6 - 8 hours; do not exceed 8 tablets in a 24-hour period
  • children under 12 years of age: consult a doctor

Other Information

  • store at room temperature 59° to 86°F (15° to 30°C)
  • Avoid excessive heat and humidity

TAMPER EVIDENCE: Do not use if packet is open or torn.

Inactive Ingredients


Corn starch, crospovidone, microcrystalline cellulose, povidone k30, silicon dioxide, stearic acid, talc, water

Questions & Comments?


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


NDC 69729-143-06

COLDTAC Plus

Tablets

Acetaminophen 325 mg / Guaifenesin 200 mg

Dextromethorphan HBr 15 mg / Phenylephrine HCl 5 mg

Effective and quick relief from

cough, cold & flu symptoms

Pain reliever, fever reducer

Nasal Decongestant

Cough Suppressant

Expectorant

Contents 12 Tablets

Exclusively distributed by OPMX

San Diego, CA 92154

Phone: 619-600-5632

Package Label.principal Display Panel






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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