FDA.reportPublic FDA data

Daytime and Nighttime Severe Cold and Flu combo pack

Manufacturer
Genexa Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:03

Label at a glance#

ProductDaytime and Nighttime Severe Cold and Flu combo pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure21 sections

Storage and handling

Other information store between 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Daytime Severe Cold & Flu

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Cough suppressant

INDICATIONS & USAGE SECTION

Uses

  • temporarily reduces fever and relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough due to minor throat and bronchial irritation
  • controls the impulse to cough to help you get to sleep

WARNINGS SECTION

Warnings

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 for this product
  • 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.

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • SHAKE WELL before each use
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over20 mL every 4 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

STORAGE AND HANDLING SECTION

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, purified water, xylitol

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Nighttime Severe Cold & Flu

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these common cold and flu symptoms:
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

WARNINGS SECTION

Warnings

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 for this product
  • 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.

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • 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
  • glaucoma
  • trouble urinating due to enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • ​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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • SHAKE WELL before each use
  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours
adults & children 12 yrs & over20 mL every 6 hours
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

STORAGE AND HANDLING SECTION

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water

OTC - QUESTIONS SECTION

Questions? 1-855-426-3921

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Tamper evident: Do not use if seal under the cap is disturbed or missing.

SHAKE WELL before each use.

U.S. Patent No. 11,617,795 | Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0095-3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Day & Night Combo Pack

Genexa®

MEDICINE MADE CLEAN

Daytime

Maximum Strength

Severe Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Body Aches & Pains

Sore Throat

Cough

Nighttime

Severe • Maximum Strength

Nighttime Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Fever

Headache

Sore Throat

Body Aches & Pains

Cough

Sneezing

Runny Nose

Medicine made clean

Same effective active ingredients, but no artificial fillers.

TWO - 6 FL OZ (177 mL) BOTTLES

TOTAL - 12 FL OZ (355 mL)

Organic Blueberry Flavor

10052-GNX_R-2024031510052-GNX_R-20240315

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2693777{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension) } PackGPCK2
26937771 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG in 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension) PackPSN2
2693772acetaminophen 650 MG / dextromethorphan HBr 20 MG in 20 mL Oral SuspensionPSN2
2692302acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SuspensionPSN2
2693772acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSCD2
2692302acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SuspensionSCD2
26937771 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension) PackSY2
2693772acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral SuspensionSY2
2693772acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral SuspensionSY2
2692302acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SuspensionSY2
2693772APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSY2
2692302APAP 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SuspensionSY2

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-130850015736643GTIN-13: 0850015736643
EAN-13: 0850015736643
GTIN-12: 850015736643
UPC-A: 850015736643
GTIN storage (14 digits): 00850015736643		10052-GNX_R-20240315 Carton.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
69676-0093-9Daytime and Nighttime Severe Cold and Flu combo pack177 mL in 1 BOTTLESUSPENSION177 mL650 mg in 20mL2
69676-0094-9Daytime and Nighttime Severe Cold and Flu combo pack177 mL in 1 BOTTLESUSPENSION177 mL650 mg in 20mL2
69676-0095-3Daytime and Nighttime Severe Cold and Flu combo pack2 in 1 KITKIT22
69676-0095-3Daytime and Nighttime Severe Cold and Flu combo pack1 in 1 BOTTLEKIT12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-009569676-0095-3
69676-009369676-0093-9
69676-009469676-0094-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
XYLITOLVCQ006KQ1EIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
BLUEBERRY253RUG1X1AIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
BLUEBERRY253RUG1X1AIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
CHAMOMILEFGL3685T2XIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
ndc (package): 69676-0093-9
ndc (package): 69676-0094-9
ndc (package): 69676-0095-3
ndc (product): 69676-0095
ndc11 (package): 69676009409
ndc11 (package): 69676009309
ndc11 (package): 69676009503
spl id: 472de7bd-c0e2-bafe-e063-6394a90a5092
spl set id: 190c7eaf-dcd4-d314-e063-6294a90a6f33
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
ndc (package): 69676-0094-9
ndc11 (package): 69676009409
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
ndc (package): 69676-0093-9
ndc (product): 69676-0093
ndc11 (package): 69676009309

Reported adverse events (FAERS/openFDA)#

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