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severe congestion and cough, cold and flu (acetaminophen 325 mg diphenhydramine hydrochloride 12.5 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Rite Aid Corporation

Generic: acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl

severe congestion and cough, cold and flu kit - (acetaminophen 325 mg diphenhydramine hydrochloride 12.5 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 694     SHAPE: oval
    COLOR: blue

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

{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 suppressantExpectorantNasal decongestant

Active Ingredients


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

  • 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


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 tranquilizers

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 (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. Do not take DAY & NIGHT 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)
  • see end flap for expiration date and lot number

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 Ingredient Section


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


Rite Aid®PHARMACY

*Compare to the active ingredientsin Maximum Strength Mucinex®FAST-MAX® Day Time SevereCongestion & Cough andNight Time Cold & Flu

MAXIMUM STRENGTH

daytime severecongestion& cough

dextromethorphan HBrguaifenesin phenylephrine HCl

cough suppressantexpectorantnasal decongestant

controls cough

relieves nasal &chest congestion

thins & loosens mucus

ACTUALSIZE

20 DAYTIMECAPLETS
nighttime cold &flu

acetaminophen diphenhydramine HClphenylephrine HCl

pain reliever/fever reducerantihistamine/ cough suppressantnasal decongestant

relieves aches, fever& sore throat

controls cough

relieves nasal congestion

relieves runny nose & sneezing

ACTUALSIZE

10 NIGHTTIMECAPLETS

for ages 12+

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

*This product is not manufactured or distributed by ReckittBenckiser LLC, owner of the registered trademark MaximumStrength Mucinex® FAST-MAX® Day Time Severe Congestion& Cough and Night Time Cold & Flu.50844                ORG051764869401

DISTRIBUTED BY:RITE AID, 30 HUNTER LANECAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED,WE'LL HAPPILY REFUND YOUR MONEY.
Rite Aid 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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