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DayTime Nighttime multi symptom cold and flu relief (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Shopko Stores Operating Co., LLC.

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

DayTime Nighttime multi symptom cold and flu relief kit - (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) image

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

  1. FDA Adverse Reactions

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Active Ingredients For Nighttime (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active Ingredients For Daytime (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose For Nighttime


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose For Daytime


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses


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

Warnings


Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
  • more than 4 doses in 24 hours, which is the maximum daily amount for these products
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

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.
  • to make a child sleep (Nighttime only)

Ask a doctor before use if you have

  • liver disease
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • high blood pressure (Daytime only)
  • 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
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

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

When using these products

  • do not use more than directed

In addition, when using Nighttime:
  • 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 (Daytime only)
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or occurs with fever, 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 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 and for children even if you do not notice any signs or symptoms

Directions

  • take only as directed – see overdose warning
  • take Nighttime OR Daytime

Nighttime Softgels
  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over  swallow 2 softgels with water every 6 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use

Daytime Softgels
  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over  swallow 2 softgels with water every 4 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other Information

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

Inactive Ingredients


Nighttime D&C Yellow #10, edible white printing ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol NF, povidone, propylene glycol, purified water, sorbitan, and sorbitol

Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white printing ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol

*may contain this ingredient

Questions Or Comments?


call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel


**Compare to Vicks® Nyquil® and Vicks® Dayquil® active ingredients

**These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® and Vicks® Dayquil®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Packaged by: PL Developments

200 Hicks street Westbury

NY 11590, USA

Product Label

daytime nighttime cold and 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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