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Severe Cold and Flu Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Harmon Stores Inc.

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Severe Cold and Flu tablet, coated - image

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • cough due to minor throat & bronchial irritation
    • minor aches and pains
    • headache
    • fever
    • sore throat
  • 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 8 caplets 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION


When using this product do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

Overdose warning


Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed (see overdose warning)
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over take 2 caplets every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Other Information

  • store between 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information

Inactive Ingredients


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

Principal Display Panel


CORE VALUES

Compare to the active ingredients in Vicks® DayQuil® Severe Cold + Flu

Maximum Strength

DayTime Severe

Cold & Flu

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

Pain Reliever / Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant

For relief of:

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal / Sinus Congestion & Sinus Pressure

Cough

Chest Congestion

Actual Size

DAYTIME NON-DROWSY

24 CAPLETS



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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