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Daytime Nighttime Cold and Flu Relief Multi-Symptom

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: P & L Development, LLC
NDC Code: 59726-072

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in 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

DAYTIME

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

NIGHTTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose & sneezing

Warnings

DAYTIME NIGHTTIME

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

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

DAYTIME NIGHTTIME

  • 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

DAYTIME

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

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

DAYTIME

  • taking the blood thinning drug warfarin.

NIGHTTIME

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product,

DAYTIME

do not use more than directed.

NIGHTTIME

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

DAYTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • pain or cough 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.

DAYTIME NIGHTTIME

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 between 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients

Daytime butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol   

*may contain this ingredient

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

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

DAYTIME

daytime

Multi-Symptom Cold & Flu Relief

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

phenylephrine HCl (nasal decongestant)

  • non-drowsy
  • alcohol-free
  • antihistamine

softgels**

(**liquid-filled capsules)

NIGHTTIME

nighttime

multi-symptom cold & flu relief

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

doxylamine succinate (antihistamine)

  • alcohol-free

softgels

(**liquid-filled capsules)

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

*This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® DayQuil® and NyQuil® LiquiCaps® are registered trademarks of The Procter and Gamble Company.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

WELLNESS BASICS Daytime Nighttime Multi-Symptom Cold and Flu Relief

DAYTIME NIGHTTIME COLD AND FLU RELIEF  MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-072
Packaging
#Item CodePackage Description
1NDC:59726-072-481 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 16 
Part 21 BLISTER PACK 32 
Part 1 of 2
NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeP30;94A;215;P120;SCU1
Contains    
Packaging
#Item CodePackage Description
116 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart341
Part 2 of 2
DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeP19;95A;512;P119
Contains    
Packaging
#Item CodePackage Description
132 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/2017
Labeler - P & L Development, LLC (800014821)

Revised: 01/2018
 
P & L Development, LLC

← See all Daytime Nighttime Cold and Flu Relief Multi-Symptom brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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