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Severe Cold and Flu (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Uncompetitive N-methyl-D-aspartate Receptor Antagonist
  3. Cardinal Health 110, LLC. DBA Leader

Generic: acetaminophen. dextromethorphan hbr, guaifenesin, phenylephrine hcl 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

Severe Cold and Flu tablet, film coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant 

Uses

  • temporarily relieves common cold and flu symptoms:
  • minor aches and pains
  • sinus congestion and pressure
  • sore throat
  • fever
  • headache
  • nasal congestion
  • cough due to minor throat and bronchial irritation 
  • 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 you take
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • bulers
  • rash
  • skin reddening  

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
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the 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 exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • 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.


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 take more than directed
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive Ingredients


corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


LEADERâ„¢

NDC 70000-0289-1

Daytime ι Non-Drowsy

Severe Cold & Flu

Acetaminophen ι Dextromethorphan HBr ι Guaifenesin ι Phenylephrine HClPain Reliever / Fever Reducer ι Cough Suppressant ι Expectorant ι Nasal Decongestant

Relief of: Headache, Fever, Sore Throat, Minor Aches & Pains,Nasal/Sinus Congestion & Sinus Pressure,Cough, Chest Congestion

12 CAPLETS

Actual Size

COMPARE TO VICKS® DAYQUIL® SEVERE COLD & FLU active ingredients*

100% MoneyBack Guarantee

*This product is not manufactured or distributed by The Procter & Gamble Company,owner of the registered trademark Vicks® DayQuil® Severe Cold & Flu.

50844     REV0519B64002

TAMPER EVIDENT: DO NOT USE IF PACKAGE ISOPENED OR IF BLISTER UNIT IS TORN, BROKEN ORSHOWS ANY SIGNS OF TAMPERING

CIN 5326152   REV. 11/21

CardinalHealthâ„¢

DISTRIBUTED BY CARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com  1-800-200-6313 Essential to Care™ since 1979

© 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarksor registered trademarks of Cardinal Health.All other marks are the property of their respecting owners.

All LEADERâ„¢ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied.

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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."

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"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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