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

  1. Human OTC
  2. Archived
  3. Walgreen Company

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Cold and Flu kit - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 503     SHAPE: oval
    COLOR: yellow

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acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg - 44 503 oval yellow

cold and flu daytime severe, nighttime severe (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl) kit - 44 503 oval yellow

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)(daytime Cold & Flu Severe)


Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Active Ingredients (in Each Caplet)(nighttime Cold & Flu Severe)


Acetaminophen 325 mgChlorpheniramine maleate 2 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • sore throat
    • headache
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure (Nighttime only)
    • sneezing and runny nose (Nighttime only)
  • helps clear nasal passages (Nighttime only)
  • relieves cough to help you sleep (Nighttime only)
  • help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ( Daytime only)
  • 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
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

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.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

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 (daytime Only)


corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only)


corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?


 1-800-426-9391

Principal Display Panel


                                 DAY & NIGHT PACK
 NDC 0363-0573-08

Walgreens

DAYTIME SEVERE COLD & FLU

ACETAMINOPHEN PAIN RELIEVER /  FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANTGUAIFENESIN / EXPECTORANTPHENYLEPHRINE HCl / NASAL DECONGESTANT

Actual Size

MULTI-SYMPTOM

16 CAPLETS

Compare to Tylenol® Cold + Flu Severe Day/Night active ingredients††

NIGHTTIME SEVERE COLD & FLU

ACETAMINOPHEN PAIN RELIEVER / FEVER REDUCERCHLORPHENIRAMINE MALEATE / ANTIHISTAMINEDEXTROMETHORPHAN HBr / COUGH SUPPRESSANTPHENYLEPHRINE HCl / NASAL DECONGESTANT

Actual Size

MULTI-SYMPTOM

8 CAPLETS

24 TOTAL CAPLETS

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

Walgreens Pharmacist RecommendedWalgreens Pharmacist Survey††This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold + Flu Severe Day/Night.

50844 REV0316A50347308

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

Walgreens 100 % SATISFACTION GUARANTEED walgreens.com ©2017 Walgreen Co.
Walgreens 44-503A473C

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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