DAYTIME AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK- acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Daytime and Nighttime Severe Cold and Flu combo pack by

Drug Labeling and Warnings

Daytime 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 Severe Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough suppressant

INDICATIONS & USAGE

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

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 an 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)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

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

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
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over: 20 mL every 4 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, natural flavors, purified water, xylitol

QUESTIONS

Questions? 1-855-436-3921

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Nighttime Severe 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 an 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 enlarged 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 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
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hours

• 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? 1-855-426-3921

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

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

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK 
acetaminophen, dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0095

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0095-3	2 in 1 KIT	07/03/2024
1		1 in 1 BOTTLE; Type 0: Not a Combination Product

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

Part 1 of 2

DAYTIME SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr suspension

Product Information
Item Code (Source)	NDC: 69676-0093
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
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: 69676-0093-9	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	07/03/2024

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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 20 mL

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

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	07/03/2024

Labeler - Genexa Inc. (079751024)