Storage and handling
Other information store between 20-25ºC (68-77ºF) do not refrigerate
Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate
- Manufacturer
- Genexa Inc.
- Effective date
- 2025-07-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:06:54
Label at a glance#
ProductMaximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
Label structure22 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Daytime Cough & Chest Congestion **
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
OTC - PURPOSE SECTION
Purposes
Cough suppressant
Expectorant
INDICATIONS & USAGE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
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 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.
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).
DOSAGE & ADMINISTRATION SECTION
Directions
- SHAKE WELL BEFORE EACH USE
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
STORAGE AND HANDLING SECTION
Other information
- store between 20-25ºC (68-77ºF)
- do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural flavors, purified water
OTC - QUESTIONS SECTION
Questions? 1-855-436-3921
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Nighttime 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 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 enlarge 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 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
- only take as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 20 mL every 6 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do 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? 1-855-436-3921
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Do not take both products within 6 hours of each other.
DO NOT use if seal under the cap is disturbed or missing.
SHAKE WELL BEFORE EACH USE
*U.S. Patent No. 11,617,795 | **Patent Pending
Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com
SPL UNCLASSIFIED SECTION
Made in the USA with globally sourced ingredients
NDC 69676-0079-3
RECENT MAJOR CHANGES SECTION
Daytime Cough & Chest Congestion
Directions
- SHAKE WELL BEFORE EACH USE
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Nighttime Cold & Flu
Directions
- SHAKE WELL BEFORE EACH USE
- only take as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 20 mL every 6 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Day & Night Combo Pack
Genexa®
MEDICINE MADE CLEAN
Daytime
Maximum Strength
Cough & Chest Congestion
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Cough
Mucus
Chest Congestion
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)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2692304 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension) } Pack | GPCK | 2 |
| 2692304 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 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) Pack | PSN | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension | PSN | 2 |
| 2692303 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Suspension | PSN | 2 |
| 2692302 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SCD | 2 |
| 2692303 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension | SCD | 2 |
| 2692304 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 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) Pack | SY | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension | SY | 2 |
| 2692302 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SY | 2 |
| 2692303 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Suspension | SY | 2 |
| 2692303 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Suspension | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0077-9 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 177 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 177 mL | 400 mg in 20mL | 2 |
| 69676-0079-3 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 2 in 1 KIT | KIT | 2 | 2 | |
| 69676-0079-3 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 1 in 1 BOTTLE | KIT | 1 | 2 | |
| 69676-0094-9 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 177 mL in 1 BOTTLE | SUSPENSION | 177 mL | 650 mg in 20mL | 2 |
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
- Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate
- Cough and Chest Congestion Maximum Strength
- Dextromethorphan HBr, Guaifenesin
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- BLUEBERRY
- WATER
- AGAVE TEQUILANA JUICE
- Nighttime Severe Cold and Flu
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- ACETAMINOPHEN
- CHAMOMILE
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0079 | 69676-0079-3 |
| 69676-0077 | 69676-0077-9 |
| 69676-0094 | 69676-0094-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| BLUEBERRY | 253RUG1X1A | IACT |
| WATER | 059QF0KO0R | IACT |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| WATER | 059QF0KO0R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CHAMOMILE | FGL3685T2X | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| BLUEBERRY | 253RUG1X1A | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Daytime and Nighttime Severe Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Genexa Inc. | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2025-12-30 | Warnings | 69676-0094-9 69676009409 |
| Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Genexa Inc. | 18835205-a9e3-15c2-e063-6394a90a8107 | 2025-07-02 | Warnings | 69676-0077-9 69676-0079-3 69676-0094-9 69676-0079 69676009409 69676007903 69676007709 38f8afad-542e-ae0c-e063-6294a90a243f 18835205-a9e3-15c2-e063-6394a90a8107 |
| Cough and Chest Congestion Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | e920b700-30d3-3266-e053-2a95a90a0639 | 2025-06-24 | Warnings | 69676-0077-9 69676-0077 69676007709 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.