KIDS MULTI SYMPTOM COLD AND FLU- acetaminophen, dextromethorphan hbr suspension

Kids Multi Symptom Cold and Flu by

Drug Labeling and Warnings

Kids Multi Symptom Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 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.
• 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

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SHAKE WELL before each use.

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

Distributed by: Genexa Inc., Atlanta, GA 30324

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

Made in the USA with globally sourced ingredients

NDC: 69676-0096-9

PRINCIPAL DISPLAY PANEL

NEW FORMULA!

Genexa®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen 320 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 5 mg - Cough Suppressant

Fever

Headache

Body Aches & Pains

Sore Throat

Cough

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 fl oz (118 mL) Dosing cup included

INGREDIENTS AND APPEARANCE

KIDS MULTI SYMPTOM COLD AND FLU 
acetaminophen, dextromethorphan hbr suspension

Product Information
Product Type	HUMAN OTC DRUG	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
CITRUS FRUIT (UNII: XDK00Z8012)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
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	1 in 1 CARTON	11/20/2024
1		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	M012	11/20/2024

Labeler - Genexa Inc. (079751024)