Daytime And Nighttime Kids' Multi-symptom Cold & Flu Combo Pack

Daytime And Nighttime Kids' Multi-symptom Cold & Flu Combo Pack
SPL v5
SPL
SPL Set ID 213fe898-dace-9a0f-e063-6394a90afd64
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Acetaminophen (320 mg) Diphenhydramine (325 mg)
Inactive Ingredients
Agave Tequilana Juice Blueberry Water

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-25
Description

Kids' Nighttime Multi-Symptom Cold & Flu Drug Facts

Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and 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
Description

Kids' Nighttime Multi-Symptom Cold & Flu Drug Facts

Section 34088-5

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.

Section 42229-5

Kids' Nighttime Multi-Symptom Cold & Flu

Drug Facts

Section 43683-2

Kids' Nighttime Multi-Symptom Cold & Flu

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

Kids' Multi-Symptom - Daytime Relief

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



Section 44425-7

Other information

store between 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

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).
Section 50570-1

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
Section 51727-6

Inactive ingredients

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

Section 51945-4

COMBO PACK

Genexa ®

MEDICINE MADE CLEAN

Kids' Multi-Symptom Cold & Flu

Ages 4+

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Sore Throat

Cough

Body Aches & Pains

Kids' Nighttime Cold & Flu

Ages 6+

Acetaminophen - Pain Reliever/Fever Reducer

Diphenhydramine HCl - Antihistamine/Cough Suppressant

Fever

Sore Throat

Body Pain

Cough

Runny Nose

Sneezing

Same active ingredients as leading brands

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

TWO - 4 FL OZ (118 mL) BOTTLES

TOTAL - 8 FL OZ (236 mL)

Organic Blueberry Flavor

Section 53413-1

Questions? 1-855-436-3921

Section 55105-1

Purposes

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

Section 55106-9

Active ingredients

(in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

Kids' Nighttime Multi-Symptom Cold & Flu

Drug Facts

Section 43683-2 (43683-2)

Kids' Nighttime Multi-Symptom Cold & Flu

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

Kids' Multi-Symptom - Daytime Relief

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



Section 44425-7 (44425-7)

Other information

store between 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

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).
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

COMBO PACK

Genexa ®

MEDICINE MADE CLEAN

Kids' Multi-Symptom Cold & Flu

Ages 4+

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Sore Throat

Cough

Body Aches & Pains

Kids' Nighttime Cold & Flu

Ages 6+

Acetaminophen - Pain Reliever/Fever Reducer

Diphenhydramine HCl - Antihistamine/Cough Suppressant

Fever

Sore Throat

Body Pain

Cough

Runny Nose

Sneezing

Same active ingredients as leading brands

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

TWO - 4 FL OZ (118 mL) BOTTLES

TOTAL - 8 FL OZ (236 mL)

Organic Blueberry Flavor

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

Section 55106-9 (55106-9)

Active ingredients

(in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.540485 · Updated: 2026-03-14T23:11:23.873993