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Generic: acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride 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

Active Ingredients


Boxed Warning section


Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purposes


Boxed Warning section


Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant


Uses


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

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 daily while using this product

  •  Acetaminophen may cause severe skin reactions. Symptoms may include:
  •   â—Źskin reddeningâ—Ź bulersâ—Ź 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • •thyroid disease
  • •diabetes
  • •high blood pressure
  • •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.

Stop use and ask a doctor if

  • •you get nervous, dizzy or sleepless
  • •pain, nasal congestion or cough get worse or last 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. Quick medical attention is critical for adults & 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 & children 12 years and over

2 Softgels with water every 4 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

Other Information

  • •store at room temperature

Inactive Ingredients


FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?


1-888-952-0050


Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

Principal Display Panel - 10 Softgel Carton


ASSURED

COMPARE TO ACTIVE INGREDIENTS IN VICKS ®DAYQUIL®

Multi-Symptom

DayTime

Liquid Capsules
  • • Acetaminophen- Pain Reliever/Fever Reducer
  • • Dextromethorphan HBr- Cough Suppressant
  • • Phenylephrine HCl -Nasal Decongestant

Fever, Headache, Sore Throat, Coughing, Minor Aches and Pains, & Nasal congestion

10 Softgels

COMPARE TO ACTIVE INGREDIENT IN VICKS DAYQUIL®

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Procter & Gamble distributor of Vicks®DayQuil® Cold &Flu LiquiCaps®

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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