Kids' Multi-symtpom Cold and Flu
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 10 mL)
Acetaminophen 320 mg
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
OTC - PURPOSE SECTION
Purposes
Pain Reliever/Fever Reducer
Cough suppressant
Expectorant
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
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.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water
OTC - QUESTIONS SECTION
Questions?
1-855-436-3921
SPL UNCLASSIFIED SECTION
SHAKE WELL before each use.
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
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 69676-0087-9
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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