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Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain 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


Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylphrine HCl 5 mg

Otc - Purpose Section


Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Indications & Usage Section


Uses temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings Section


Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION


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.

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, 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.

OTC - STOP USE SECTION


Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get 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 (1-800-222-1222) right away.

Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Dosage & Administration Section


Directions
  • take only as directed
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over: 2 softgels with water every 4 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

Other Safety Information


Other information
  • store at room temperature

Inactive Ingredient Section


Inactive ingredients FD&C Red#40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Otc - Questions Section


Questions? Call 1-877-290-4008

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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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