Nighttime Cold and Flu

Manufacturer
P & L Development, LLC
Effective date
2023-06-01
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:30:39

Label at a glance#

ProductNighttime Cold and Flu ReadyInCase
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter Keep dosing cup with product adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use  When using Day Time and Night Time products, carefully read each label to ensure correct...

Storage and handling

each 30 mL contains: potassium 5 mg each 30 mL contains: sodium 19 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

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

Allergy alert: Acetaminophen may cause severe skin reaction. 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

OTC - DO NOT USE SECTION

  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • 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 an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • new symptoms 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • Keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use 
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 19 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfae potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Vicks® NyQuil®* Cold & Flu*

Night Time

Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine succinate

Relieves:

  • headaches, fever, sore throat, minor ache and pains
  • cough
  • runny nose & sneezing

For ages 12 years & over

nighttime relief

Alcohol 10%

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReadyinCase NightTime Cold & Flu
ReadyinCase NightTime Cold & Flu

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49580-0344-62023-06-01C16284748780-1f386c649-f34a-0266-e053-dadaa90a7c1aDrug Facts
49580-0344-62023-01-30C16284748780-1f386c649-f34a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI22
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95K2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-034449580-0344-6, 49580-0344-2, 49580-0344-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 378 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
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POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQSOLUTION / TOPICAL29.7 %w/wExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / OPHTHALMIC0.09 %w/vExact identifier — unii candidate
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SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / TOPICAL186 mgExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSHAMPOO / TOPICAL186 mgExact identifier — unii candidate
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SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRACARDIAC25 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / ORAL5013 mgExact identifier — unii candidate
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TRISODIUM CITRATE DIHYDRATETRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii candidate
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D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
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FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM / SUBLINGUAL11 mgExact identifier — unii candidate
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D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
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D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / ORAL8 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii candidate
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D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
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FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
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FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER / ORAL20 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
99c28642-afbc-4eb3-8a3a-636e51bfb976c792a9ff-973e-4d69-9c6b-b4a7dd2620f92023-06-01WarningsExact identifier
spl id: 99c28642-afbc-4eb3-8a3a-636e51bfb976
spl set id: c792a9ff-973e-4d69-9c6b-b4a7dd2620f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.