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Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, and 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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Drug Facts

Otc - Active Ingredient Section


Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION


Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses


temporarily relieves common cold/flu symptoms:
  • •nasal congestion
  • •sinus congestion & pressure
  • •cough due to minor throat & bronchial irritation
  • •cough to help you sleep
  • •minor aches & pains
  • •headache
  • •fever
  • •sore throat
  • •runny nose & 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 you take
  • •more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • •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
  • •glaucoma
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • •trouble urinating due to enlarged prostate gland
  • •a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

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

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 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.


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

  • •take only as directed
  • •only use the dose cup provided
  • •do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use



Other Information

  • • each 30 mL contains: sodium 81 mg
  • •Store at room temperature. Do not refrigerate.

Inactive Ingredients


citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions?


1-866-467-2748


Distributed by:

Principal Display Panel - 354ml Bottle Label


*Compare to the active ingredients in VICKS ® NyQuil™ Severe + VapoCOOL™

NDC 0363-6142-12

NightTime Cold & Flu Relief

Acetaminophen- Pain reliever/Fever reducer

Dextromethorphan HBr – Cough suppressant

Doxylamine Succinate - Antihistamine

Phenylephrine HCl – Nasal decongestant For Relief of
  • •Minor Aches & Pains, Fever
  • •Nasal Congestion & Sinus Pressure
  • •Sneezing, Runny Nose
  • •Cough

For Ages 12+

12 FL OZ (354 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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