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Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


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Active Ingredients (in Each 15 Ml)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses


temporarily relieves common cold/flu symptoms:
  • •nasal congestion
  • •sinus congestion and pressure
  • •cough due to minor throat and bronchial irritation
  • •cough to help you sleep
  • •minor aches and pains
  • •headache
  • •sore throat
  • •fever
  • •runny nose and sneezing
  • •reduces swelling of nasal passages
  • •temporarily restores freer breathing through the nose
  • •promotes nasal and/or sinus drainage

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if
  • •adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •child takes more than 5 doses in 24 hours
  • •taken with other drugs containing acetaminophen
  • •adult has 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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients
  • •to make a child sleepy

Ask a doctor before use if you have

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

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 use more than directed
  • •excitability may occur, especially in children
  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery
  • •alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • •you get nervous, dizzy or sleepless
  • •pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • •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.

If pregnant or breast-feeding,


ask a health professional before use.

Keep out of reach of children.


Overdose warning: 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
  • •only use the dose cup provided
  • •do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrschildren 6 to under 12 yrs15 mL every 4 hrschildren 4 to under 6 yrsask a doctorchildren under 4 yrsdo not use
 
 
 
 
 
 
 
 

Other Information

  • • each 15 mL contains: sodium 15 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredients


anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?


1-800-719-9260

Package/label Principal Display Panel


CVS Health®

Compare to the active ingredients in Vicks® NyQuil® Severe Honey Flavor

Nighttime Severe

ACETAMINOPHEN

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

Fever, Sore throat, Minor aches & pains, Nasal congestion, Sinus pressure, Sneezing, Runny nose, Cough

COLD & FLU

Honey Flavor

12 FL OZ (355 mL)

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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