Kids' Multi-symtpom Cold And Flu

SPL v3

SPL

SPL Set ID 027469db-7d2e-753b-e063-6294a90a4355

Route

ORAL

Published

Effective Date 2023-08-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg) Acetaminophen (320 mg) Dextromethorphan (5 mg)

Inactive Ingredients

Citrus Fruit Agave Tequilana Juice Water

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-15

Description

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 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 your child get to sleep

• minor aches and pains associated with:

• the common cold • fever • sore throat

• headache • body pain

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

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 USING

• 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

Description

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

Drug Facts

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 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 persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or

persistent headache.

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 the child is taking the blood thinning drug warfarin

Section 50569-3

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) unless directed by a doctor.

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.

• 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.

Section 51727-6

Inactive ingredients

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

Section 51945-4

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen 320 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Cough

Mucus

Chest Congestion

Sore Throat

Fever

Body Pain

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 FL OZ (118 mL) Liquid

Dosing cup included

Section 53413-1

Questions?

1-855-436-3921

Section 55105-1

Purposes

Pain Reliever/Fever Reducer

Cough suppressant

Expectorant

Section 55106-9

Active ingredients (in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

• 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 your child get to sleep

• minor aches and pains associated with:

• the common cold • fever • sore throat

• headache • body pain

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

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 USING

• 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

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)

Drug Facts

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 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 persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or

persistent headache.

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 the child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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) unless directed by a doctor.

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.

• 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.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen 320 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5mg - Cough Suppressant

Guaifenesin 100 mg - Expectorant

Cough

Mucus

Chest Congestion

Sore Throat

Fever

Body Pain

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 FL OZ (118 mL) Liquid

Dosing cup included

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 55105-1 (55105-1)

Purposes

Pain Reliever/Fever Reducer

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "320", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRUS FRUIT", "unii": "XDK00Z8012", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • 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 your child get to sleep • minor aches and pains associated with: • the common cold • fever • sore throat • headache • body pain • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "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 USING • 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", "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.", "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.", "42229-5": "Drug Facts", "44425-7": "Other information store between 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if • pain 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 persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 the child is taking the blood thinning drug warfarin", "50569-3": "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) unless directed by a doctor.", "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. • 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.", "51727-6": "Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water", "51945-4": "Genexa® MEDICINE MADE CLEAN Ages 4+ Kids' Multi-Symptom Cold & Flu Acetaminophen 320 mg - Pain Reliever/Fever Reducer Dextromethorphan HB r 5mg - Cough Suppressant Guaifenesin 100 mg - Expectorant Cough Mucus Chest Congestion Sore Throat Fever Body Pain Medicine made clean Same effective active ingredients, but no artificial fillers. Organic Blueberry Flavor 4 FL OZ (118 mL) Liquid Dosing cup included", "53413-1": "Questions? 1-855-436-3921", "55105-1": "Purposes Pain Reliever/Fever Reducer Cough suppressant Expectorant", "55106-9": "Active ingredients (in each 10 mL) Acetaminophen 320 mg Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.834802 · Updated: 2026-03-14T23:02:00.533418