Nite-Time

Manufacturer
AptaPharma Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:28:43

Label at a glance#

ProductNite-Time COLD/FLU Medicine Cherry
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

take only as recommended-see Overdose warning Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours ---------------------------------------------------------------------------------------------------------------------- adults and children 12 years and over                30 mL (2 TBSP) every 6 hours ____________________________________________________________________ children 4 to under 12 years    ...

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 alcohol 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, or headache that lasts

These could be signs of a serious condition.

Pregnancy 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

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

----------------------------------------------------------------------------------------------------------------------
adults and children 12 years and over                30 mL (2 TBSP) 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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients :citric acid, FD and C Blue No. 1, FD and C Red No. 40, 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 afet 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 Multi-Symptom Cherry Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76281-502-28

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

Cherry Flavor

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Questions?Call weekdays 1-877-798-5944

*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

502-28 12oz Botl502-28 12oz Botl

6 oz

502 6oz label502 6oz label

​4 oz

4 oz label4 oz label

4oz4oz

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 SolutionPSN11
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD11
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY11
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY11
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY11

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-130376281502251GTIN-13: 0376281502251
EAN-13: 0376281502251
GTIN-12: 376281502251
UPC-A: 376281502251
GTIN storage (14 digits): 00376281502251
502 6oz label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-502-24Nite-TimeCOLD/FLU Medicine Cherry118 mL in 1 BOTTLELIQUID11811
76281-502-25Nite-TimeCOLD/FLU Medicine Cherry177 mL in 1 BOTTLELIQUID17711
76281-502-28Nite-TimeCOLD/FLU Medicine Cherry354 mL in 1 BOTTLELIQUID35411

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-50276281-502-28, 76281-502-25, 76281-502-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-11-07monthly-update2026-06-03 17:38:33
92023-12-11full-release2026-06-01 00:03:54

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 Medicine CherryACETAMINOPHENAptaPharma Inc.87c2b823-ed88-44f3-8f6a-df30430b40f32025-12-26WarningsExact identifier
ndc (package): 76281-502-25
ndc (package): 76281-502-28
ndc (package): 76281-502-24
ndc (product): 76281-502
ndc11 (package): 76281050225
ndc11 (package): 76281050228
ndc11 (package): 76281050224
spl id: 46e2d507-7545-48c8-e063-6294a90a6c67
spl set id: 87c2b823-ed88-44f3-8f6a-df30430b40f3

Reported adverse events (FAERS/openFDA)#

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