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Generic: acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial


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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each 30 mL dose cup) Purpose

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Uses


temporarily relieves common cold/flu symptoms:
  • â–ªcough due to minor throat and bronchial irritation
  • â–ªsore throat
  • â–ªheadache
  • â–ªminor aches and pains
  • â–ªfever
  • â–ªrunny nose and sneezing

Warnings


Liver warning


This product contains acetaminophen. Severe liver damage may occur if you take
  • â–ªmore than 4 doses (30 mL each dose) in 24 hours, which is the maximum daily amount for this product
  • â–ªwith other drugs containing acetaminophen
  • â–ª3 or more alcoholic drinks every day while using this product


Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • â–ªSkin reddening
  • â–ªBulers
  • â–ªRash

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

  • â–ªwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • â–ªif 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

  • â–ªliver disease
  • â–ªglaucoma
  • â–ªcough that occurs with too much phlegm (mucus)
  • â–ªa breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • â–ªtrouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • â–ªtaking sedatives or tranquilizers
  • â–ªtaking the blood thinning drug warfarin

When using this product

  • â–ªexcitability may occur, especially in children
  • â–ªmarked drowsiness may occur
  • â–ªavoid alcoholic drinks
  • â–ªbe careful when driving a motor vehicle or operating machinery
  • â–ªalcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • â–ªpain or cough gets worse or lasts more than 7 days
  • â–ªfever gets worse or lasts more than 3 days
  • â–ªredness or swelling is present
  • â–ªnew symptoms occur
  • â–ªcough 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


In case of overdose, get medical help or contact a Poison Control Center right away at 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

  • â–ªtake only as directed
  • â–ªuse dose cup provided
  • â–ªdo not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL per dose every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other Information

  • • each 30 mL contains: sodium16 mg
  • •store at room temperature

Inactive Ingredients


Anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions?


1-866-467-2748


Distributed by

Principal Display Panel - 236 Ml Bottle Label


Compare to the active ingredients in Vicks® NyQuil™ High Blood Pressure Cold & Flu*

NDC 0363-6210-08

High Blood

Pressure

Nighttime

Cold & Flu

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat,

Minor Aches & Pains

Sneezing, Runny Nose

Cough

Sugar Free & No Added Alcohol

8 FL OZ (236 mL)

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ High Blood Pressure Cold & Flu.

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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