Nite-Time

Manufacturer
AptaPharma Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:28:37

Label at a glance#

ProductNite-Time COLD/FLU Medicine
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

Indications and uses

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

Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over                     30 mL (2TBSP) every 6 hours children 4 to under 12 years                                   ask a doctor children under 4 years                                            do not use If taking Nite Time at night and Day Time during th...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Purpose

OTC - PURPOSE SECTION

Purpose

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

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

Warnings

WARNINGS SECTION

Liver warning:This product contains acetaminophen. Severe liver damage
may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is
the maximum daily amount for this product ● with other drugs containing
acetaminophen ● 3 or more alcoholic drinks everyday 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.

Ask A Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use

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

When Using This Product

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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

Pregnant Or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning

OVERDOSAGE SECTION

Overdose warning: 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

Directions

  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours


adults and children 12 years and over                     30 mL (2TBSP) every 6 hours
children 4 to under 12 years                                   ask a doctor
children under 4 years                                            do not use

  • If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Other Information

OTHER SAFETY INFORMATION

Other information

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: 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

Do Not Use

OTC - DO NOT USE SECTION

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 sleepy

Package Label - Night Time Cold & Flu Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76281-501-28

AP SAFE

*COMPARE TO
the active ingredients in
VICKS ®NYQUIL ®

Night Time

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – Antihistamine

Multi-Symptom
Cold & Flu Relief

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

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

Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110

12 OZ

501-28 12oz Botl501-28 12oz Botl

6 OZ

501-25 6 OZ501-25 6 OZ

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 SolutionPSN9
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD9
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY9
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY9
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376281501285GTIN-13: 0376281501285
EAN-13: 0376281501285
GTIN-12: 376281501285
UPC-A: 376281501285
GTIN storage (14 digits): 00376281501285
501-28 12oz Botl.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-501-25Nite-TimeCOLD/FLU Medicine177 mL in 1 BOTTLELIQUID1779
76281-501-28Nite-TimeCOLD/FLU Medicine354 mL in 1 BOTTLELIQUID3549

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-50176281-501-28, 76281-501-25

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

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
Nite-Time COLD/FLU MedicineACETAMINOPHENAptaPharma Inc.344440bc-d810-4296-93ec-e6ae6673856b2025-12-26WarningsExact identifier
ndc (package): 76281-501-28
ndc (package): 76281-501-25
ndc (product): 76281-501
ndc11 (package): 76281050125
ndc11 (package): 76281050128
spl id: 46e2c8b6-bd83-7100-e063-6294a90ac998
spl set id: 344440bc-d810-4296-93ec-e6ae6673856b

Reported adverse events (FAERS/openFDA)#

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