MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK- dextromethorphan hbr, guaifenesin, acetaminophen, doxylamine succinate kit

Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack by

Drug Labeling and Warnings

Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Daytime Cough & Chest Congestion **

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

PURPOSE

Purposes

Cough suppressant

Expectorant

INDICATIONS & 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

WARNINGS

Warnings

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.

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)

When using this product do not use more than directed

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.

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

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

• 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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water

QUESTIONS

Questions? 1-855-436-3921

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Nighttime Cold & Flu*

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE

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

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.

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.

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

Ask a doctor or pharmacist before use if you are

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

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

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.

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

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

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions? 1-855-436-3921

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK 
dextromethorphan hbr, guaifenesin, acetaminophen, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0079

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0079-3	2 in 1 KIT	05/31/2024
1		1 in 1 BOTTLE; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	177 mL
Part 2	1 BOTTLE	177 mL

Part 1 of 2

COUGH AND CHEST CONGESTION MAXIMUM STRENGTH 
dextromethorphan hbr, guaifenesin suspension

Product Information
Item Code (Source)	NDC: 69676-0077
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
BLUEBERRY (UNII: 253RUG1X1A)
CITRUS FRUIT (UNII: XDK00Z8012)
WATER (UNII: 059QF0KO0R)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)

Product Characteristics
Color	brown (Golden)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0077-9	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/12/2024

Part 2 of 2

NIGHTTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate suspension

Product Information
Item Code (Source)	NDC: 69676-0094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CHAMOMILE (UNII: FGL3685T2X)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
BLUEBERRY (UNII: 253RUG1X1A)

Product Characteristics
Color	brown (Light)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0094-9	177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/31/2024

Labeler - Genexa Inc. (079751024)