DAYTIME AND NIGHTTIME KIDS MULTI-SYMPTOM COLD AND FLU COMBO PACK- acetaminophen, dextromethorphan hbr, diphenhydramine hcl kit

Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack by

Drug Labeling and Warnings

Daytime and Nighttime Kids Multi-Symptom 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

Kids' Nighttime Multi-Symptom Cold & Flu

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

INDICATIONS & USAGE

Uses

temporarily reduces fever and relieves these common cold/flu symptoms:

minor aches and pains
headache
cough due to minor throat and bronchial irritation
sore throat
runny nose
sneezing
controls the impulse to cough to help your child get to sleep

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Ask a doctor or pharmacist before use if the child is

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

When using this product

• do not use more than directed
• marked drowsiness may occur
• sedatives and tranquilizers may increase the drowsiness effect
• excitability may occur, especially in children

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• SHAKE WELL before each use
• for accurate dosing, use measuring cup provided. Do not use with any other dosing device.
• children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last, do not give more than 5 times in 24 hours
• children under 6 years of age: do not use unless directed by a doctor

STORAGE AND HANDLING

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

SHAKE WELL before each use.

Keep outer package for complete product information

Tamper evident: Do not use if perforated band around the bottle is disturbed or missing.

SPL UNCLASSIFIED SECTION

Kids' Multi-Symptom Cold & Flu - Daytime Relief

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

PURPOSE

Purposes

Pain reliever/fever reducer

Cough Suppressant

INDICATIONS & USAGE

Uses

• temporarily reduces fever and relieves these common cold/flu symptoms:
• minor aches & pains
• headache
• cough due to minor throat and bronchial irritation
• sore throat

• controls the impulse to cough to help your child get to sleep

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 2 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.
• in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Ask a doctor or pharmacist before use if the child is 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 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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 even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• SHAKE WELL before each use
• find right dose on chart below
• for accurate dosing, use measuring cup provided. Do not use with any other dosing device.
• give dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

• children 6 to under 12 years: 10 mL every 4 hours
• children 4 to under 6 years: 7.5 mL every 4 hours
• children under 4 years: 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 citrus extract, natural flavor, purified water

QUESTIONS

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

Distributed by: Genexa Inc., Atlanta, GA 30324 |

genexa.com | U.S. Patent No. 11,617,795

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC: 69676-0092-3

PRINCIPAL DISPLAY PANEL

DAYTIME + NIGHTTIME VALUE PACK

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu Daytime Relief

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5mg - Cough Suppressant

Fever

Headache

Body Aches & Pains

Sore Throat

Cough

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

Ages 6+

Kids' Nighttime Multi-Symptom Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Diphenhydramine HCl - Antihistamine/Cough Suppressant

Fever

Sore Throat

Body Pain

Cough

Runny Nose

Sneezing

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

TWO - 4 FL OZ (118 mL) BOTTLES

TOTAL - 8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME KIDS MULTI-SYMPTOM COLD AND FLU COMBO PACK 
acetaminophen, dextromethorphan hbr, diphenhydramine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0092

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0092-3	2 in 1 KIT	06/25/2024
1		1 in 1 BOTTLE; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

KIDS MULTI SYMPTOM COLD AND FLU 
acetaminophen, dextromethorphan hbr suspension

Product Information
Item Code (Source)	NDC: 69676-0096
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 10 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	320 mg  in 10 mL

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

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: 69676-0096-9	118 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

Part 2 of 2

KIDS NIGHTTIME MULTI SYMPTOM COLD AND FLU 
acetaminophen, diphenhydramine hcl suspension

Product Information
Item Code (Source)	NDC: 69676-0091
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 10 mL

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

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: 69676-0091-9	118 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	06/25/2024

Labeler - Genexa Inc. (079751024)