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DayTime NightTime Cold/Flu (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. QUALITY CHOICE (Chain Drug Marketing Association)

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

DayTime NightTime Cold/Flu kit - (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 Ingredientsin Daytime (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active Ingredientsin Nighttime (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose For Daytime


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose For Nighttime


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • cough due to minor throat and bronchial irritation
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)

Warnings


Liver warning: These products contain 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

  • to make a child sleep (Nighttime only)
  • 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
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis 
  • glaucoma (Nighttime only)
  • diabetes (Daytime only)
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product,


do not exceed recommended dosage. In addition, when using Nighttime:
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur (Daytime only)
  • pain, cough, and (for Daytime only) nasal congestion 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.

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
  • swallow whole; do not crush, chew, or dissolve

Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours.
  • children under 12 years: do not use

Other Information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive Ingredients


Inactive ingredients in Daytime   butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol     *may contain this ingredient

Inactive ingredients in Nighttime   D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions Or Comments?


Call 1- 248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel


**Compare to the active ingredients in VICKS® DAYQUIL® and NYQUIL® LIQUICAPS®

Non-Drowsy DayTime

Multi-Symptom Relief for Cold/Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

NightTime

Multi-Symptom Relief for Cold/Flu

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Softgels

**This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI  48376-0995

www.qualitychoice.com

Questions: 248-449-9300

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Product Label

Quality Choice Daytime Nighttime Cold and Flu Softgel

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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