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Day Time Cold non drowsy cold and Flu Relief (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Chain Drug Consortium, LLC

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Day Time Cold non drowsy cold and Flu Relief solution - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: P19 95A 36A     SHAPE: capsule
    COLOR: orange

  1. FDA Adverse Reactions

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Active Ingredients (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 15 mg 

Purpose


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

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

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

Ask a doctor or pharmacist before use if you are


taking the blood thinning drug warfarin.

When using this product,


do not exceed the recommended dosage.

Stop use and ask a doctor if

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Day time or Night time products, carefully read each label to insure correct dosing

Other Information

  • store at room temperature 15º-30ºC (59º-86ºF)
  • avoid excessive heat

Inactive Ingredients


butylated hydroxyanisole, butylated hydroxytoluene, carmine, D&C yellow #10, FD&C red #40, FD&C yellow #6, gelatin, glycerin USP, mannitol, polyethylene glycol 400 NF, polyethylene glycol 600, povidone, propylene glycol USP, sodium metabisulfite, sorbitan, sorbitol

Principal Display Panel


Premier Value

Day- Time

Non- Drowsy Cold/ Flu Relief

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain reliever, fever reducer, cough suppressant, nasal decongestant

*Compare to active ingredients 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

SEE NEW WARNINGS INFORMATION

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

2300 NW CORPORATE BLVD., SUITE 115

BOCA RATON, FL 33431

QUESTIONS OR COMMENTS ?

CALL TOLL FREE 1-877-753-3935

Product Label


  DAY TIME NON DROWSY COLD/ FLU RELIEF

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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