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Severe Cold ({8 (acetaminophen 325 mg / chlorpheniramine maleate 2 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) / 16 (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochlor) Dailymed

  1. Human OTC
  2. Archived
  3. Walgreen Company

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Severe Cold tablet, film coated - ({8 (acetaminophen 325 mg / chlorpheniramine maleate 2 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) / 16 (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochlor) image
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IMPRINT: 44 503     SHAPE: oval
    COLOR: yellow

All Imprints

{8 (acetaminophen 325 mg / chlorpheniramine maleate 2 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) / 16 (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochlor - 44 503 oval yellow

  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 these common cold and flu symptoms:
    • headache
    • minor aches and pains
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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

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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 (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 directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 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, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicone dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

NDC 0363-0503-08

DAYTIMEMULTI-SYMPTOMNON-DROWSY

SevereCold

Acetaminophen / Pain Reliever / Fever ReducerDextromethorphan HBr / Cough SuppressantGuaifenesin / ExpectorantPhenylephrine HCl / Nasal Decongestant

• Fever/headache, sore throat, nasal congestion,cough & chest congestion

24CAPLETS

Actual Size

Compare to Tylenol® ColdMulti-Symptom Severeactive ingredients‡‡

PSEUDOEPHEDRINE FREE • COOL BLAST FLAVOR

DISTRIBUTED BY: WALGREEN CO.200 WILMOT RD., DEERFIELD, IL 60015

Walgreens 100% SATISFACTIONGUARANTEED

walgreens.com ©2016 Walgreen Co.

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

‡Walgreens Pharmacist Survey Study, November 2014.

‡‡This product is not manufactured or distributed by McNeilConsumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Severe.   

50844   REV0316A50308

Walgreens 44-503A

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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