NIGHT-TIME

Manufacturer
DeMoulas Market Basket | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:03

Label at a glance#

ProductNIGHT-TIME MULTI-SYMPTOM COLD/FLU Original
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure17 sections

Indications and uses

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

Dosage and administration

take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Label contents#

Full prescribing information#

Drug Facts Active ingredients (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg  

Dextromethorphan HBr 30 mg  

Doxylamine Succinate 12.5 mg  

Purpose

OTC - PURPOSE SECTION


Pain reliever/fever reducer   

Cough suppressant   

Antihistamine  

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cold/flu symptoms:

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

Warnings

WARNINGS SECTION

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take 

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy Alert:Acetaminophen may causesevere skin reactions. Symptoms may include:

  • skinreddening
  • blisters
  • rash

If a skin reactions occurs, stop 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

  •  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 sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a sodium restricted diet
  • 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 enlarged prostate gland

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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

  •  redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, 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.

Overdose warning

OVERDOSAGE SECTION

 Taking more than the recommended dose 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 as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours
AptaPharmaMB NightTime MS2 Label
AptaPharmaMB NightTime MS2 Label

Other information

OTHER SAFETY INFORMATION

  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

OTC - QUESTIONS SECTION

Call weekdays

1-877-798-5944

Market Basket Night-Time product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MARKET BASKET®

"MORE FOR YOUR DOLLAR"

* COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®

NIGHT-TIME

MULTI-SYMPTOM COLD/FLU  RELIEF


Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to followthese warnings could result in serious complications

*This product is not manufactured or distributed by Proctor & Gamble, distributor of Vicks® Nyquil®   LR-002

Made in the USA

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET - TEWKSBURY, MA 01876

LR - 034 REV 01


AptaPharma MB NightTimeAptaPharma MB NightTime

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN8
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD8
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY8
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY8
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-501-28NIGHT-TIMEMULTI-SYMPTOM COLD/FLU Original354 mL in 1 BOTTLELIQUID3548

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-501NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]8Current NDC, Legacy NDC, 1 package rows20231230_eb24323f-82a1-4ba3-9359-fe81571c3fba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D6
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH6
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI26
ACETAMINOPHENACTIVE MOIETY362O9ITL9D6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS6
DOXYLAMINEACTIVE MOIETY95QB77JKPL6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A86
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR6
SUCROSEINACTIVE INGREDIENTC151H8M5546
WATERINACTIVE INGREDIENT059QF0KO0R6

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
53942-50153942-501-28

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 · Source PDF

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 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / ORAL8 mgExact identifier — unii+route
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii+route
42 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SELIXIR / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSYRUP / ORAL4 mgExact identifier — unii+route
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET, COATED / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET / ORAL240 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCONCENTRATE / ORAL0.03 mg/1mlExact identifier — unii+route
42 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii+route
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii+route
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii+route
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii+route
42 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii+route
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii+route
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route
34 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET, COATED / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
NIGHT-TIME MULTI-SYMPTOM COLD/FLU OriginalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDeMoulas Market Basketeb24323f-82a1-4ba3-9359-fe81571c3fba2023-12-29WarningsExact identifier
ndc (package): 53942-501-28
ndc (product): 53942-501
ndc11 (package): 53942050128
spl id: 0dac168e-499b-525a-e063-6294a90a089a
spl set id: eb24323f-82a1-4ba3-9359-fe81571c3fba

Reported adverse events (FAERS/openFDA)#

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