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

  1. Human OTC
  2. Uncompetitive N-methyl-D-aspartate Receptor Antagonist
  3. Meijer Distribution Inc

Generic: acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl is used for the treatment of Cough Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

Severe Cough and Congestion and Cold and Flu kit - (dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 648     SHAPE: oval
    COLOR: red

All Imprints

{10 (acetaminophen 325 mg / diphenhydramine hydrochloride 12.5 mg / phenylephrine hydrochloride 5 mg oral tablet) / 20 (dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet) } pack - 44 694 oval blue

acetaminophen 325 mg diphenhydramine hydrochloride 12.5 mg phenylephrine hydrochloride 5 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg - 44 648 oval red

{10 (acetaminophen 325 mg / diphenhydramine hydrochloride 12.5 mg / phenylephrine hydrochloride 5 mg oral tablet) / 20 (dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet) } pack - 44 648 oval red

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet) (daytime Severe Congestion & Cough)


Dextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Purpose


Cough suppressant Expectorant Nasal decongestant

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


Acetaminophen 325 mgDiphenhydramine HCl 12.5 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerAntihistamine/cough suppressantNasal decongestant

Uses (daytime Only)

  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • nasal congestion due to a cold
    • the intensity of coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Uses (nighttime Only)

  • temporarily relieves these common cold and flu symptoms:
    • headache
    • sore throat
    • nasal congestion
    • runny nose and sneezing
    • cough
    • minor aches and pains
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings (nighttime Only)


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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

  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
  • if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
  • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizer

When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever (Daytime only)
  • redness or swelling is present (Nighttime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
  • new symptoms occur (Nighttime only)
  • fever gets worse or lasts more than 3 days (Nighttime only)
  • 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

  • do not use more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients (daytime Only)


corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only)


corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


COMBO PACK Total 30 Caplets

NDC 41250-848-01

Meijer®

Compare to MaximumStrength Mucinex® FAST-MAX® DAY TIMESevere Congestion& Coughactive ingredients*

Daytime severecough &congestion

Dextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Cough SuppressantExpectorantNasal Decongestant

MAXIMUM STRENGTH

• Controls Cough,• Relieves Nasal & Chest Congestion• Thins & Loosens Mucus

20 Caplets

Actual Size 
Meijer®

Compare to MaximumStrength Mucinex® FAST-MAX® NIGHT TIMECold & Fluactive ingredients*

Nighttime

cold &flu

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mgPhenylephrine HCl 5 mg

Pain Reliever/Fever ReducerAntihistamine/Cough SuppressantNasal Decongestant

MAXIMUM STRENGTH

• Relieves Aches, Fever & Sore Throat• Relieves Nasal Congestion, Runny nose& Sneezing • Controls Cough

10 Caplets

Actual Size 

*This product is not manufactured or distributed by RB Health(US) LLC, owner of the registered trademark MaximumStrength Mucinex® FAST-MAX® Day Time Severe Congestion& Cough and Night Time Cold & Flu.50844 REV1021B64869401

DIST. BY MEIJERDISTRIBUTION, INC.GRAND RAPIDS, MI 49544www.meijer.com

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF PACKAGE ISOPENED OR IF BLISTER UNIT IS TORN, BROKENOR SHOWS ANY SIGNS OF TAMPERING
Meijer 44-648694

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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