Maximum Strength Cough And Chest Congestion And Nighttime Cold And Flu Severe Combo Pack

SPL v2

SPL

SPL Set ID 18835205-a9e3-15c2-e063-6394a90a8107

Route

ORAL

Published

Effective Date 2025-07-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg) Dextromethorphan (20 mg) Acetaminophen (650 mg) Doxylamine (30 mg)

Inactive Ingredients

Blueberry Water Agave Tequilana Juice Chamomile

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-31

Description

Daytime Cough & Chest Congestion ** Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

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

Description

Daytime Cough & Chest Congestion ** Drug Facts

Section 42229-5

Daytime Cough & Chest Congestion **

Drug Facts

Section 43683-2

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

Section 44425-7

Other information

store between 20-25ºC (68-77ºF)
do not refrigerate

Section 50565-1

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).

Section 50566-9

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.

Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

Section 50569-3

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)

Section 50570-1

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.

Section 51727-6

Inactive ingredients

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

Section 51945-4

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)

Section 53413-1

Questions? 1-855-436-3921

You may also report side effects to this phone number.

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant

Expectorant

Section 55106-9

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Daytime Cough & Chest Congestion **

Drug Facts

Section 43683-2 (43683-2)

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

Section 44425-7 (44425-7)

Other information

store between 20-25ºC (68-77ºF)
do not refrigerate

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

You may also report side effects to this phone number.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BLUEBERRY", "unii": "253RUG1X1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BLUEBERRY", "unii": "253RUG1X1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings", "42229-5": "Daytime Cough & Chest Congestion ** Drug Facts", "43683-2": "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", "44425-7": "Other information store between 20-25ºC (68-77ºF) do not refrigerate", "50565-1": "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).", "50566-9": "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.", "50567-7": "When using this product do not use more than directed", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin", "50569-3": "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)", "50570-1": "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.", "51727-6": "Inactive ingredients organic agave syrup, organic blueberry flavor, natural flavors, purified water", "51945-4": "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)", "53413-1": "Questions? 1-855-436-3921 You may also report side effects to this phone number.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purposes Cough suppressant Expectorant", "55106-9": "Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:29.123817 · Updated: 2026-03-14T23:09:16.713853