Storage and handling
Other information store between 20-25°C (68-77°F) do not refrigerate
Kids' Multi-Symptom Cold and Flu
- Manufacturer
- Genexa Inc.
- Effective date
- 2026-05-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:03:36
Label at a glance#
ProductKids Multi Symptom Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure12 sections
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 10 mL)
Acetaminophen 320 mg
Dextromethorphan HBr, USP 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
INDICATIONS & USAGE SECTION
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 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).
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 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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 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 SECTION
Other information
- store between 20-25°C (68-77°F)
- do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water
OTC - QUESTIONS SECTION
Questions? 1-855-436-3921
SPL UNCLASSIFIED SECTION
SHAKE WELL BEFORE EACH USE
DO NOT use if perforated band around the bottle is disturbed or missing.
Distributed by: Genexa Inc.
Atlanta, GA 30324 | genexa.com
NDC 69676-0096-9
PARENTS: Learn about teen medicine abuse
RECENT MAJOR CHANGES 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 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 |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Genexa ®
CLEAN MEDICINE
Ages 4-11
Kids' Multi-Symptom DAYTIME Cold & Flu
ACETAMINOPHEN
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Fever, Headache, Sore Throat, Cough, Body Aches & Pains
0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens
Made with Real Agave + Blueberry Flavoring
4 FL OZ (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2693770 | acetaminophen 320 MG / dextromethorphan HBr 5 MG in 10 mL Oral Suspension | PSN | 3 |
| 2693770 | acetaminophen 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral Suspension | SCD | 3 |
| 2693770 | acetaminophen 320 MG / dextromethorphan HBr 5 MG per 10 ML Oral Suspension | SY | 3 |
| 2693770 | APAP 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral Suspension | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850015736520 | GTIN-13: 0850015736520 EAN-13: 0850015736520 GTIN-12: 850015736520 UPC-A: 850015736520 GTIN storage (14 digits): 00850015736520 | 10035-GNX carton_R-20251226.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Kids Multi Symptom Cold and Flu
- Acetaminophen, Dextromethorphan HBr
- AGAVE TEQUILANA JUICE
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0096 | 69676-0096-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-11-25 | full-release | 2026-06-01 01:23:09 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kids Multi Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Genexa Inc. | 2d918ec8-3098-1d09-e063-6294a90a9e8f | 2026-05-28 | Warnings | 69676-0096-9 69676-0096 69676009609 52ea56a8-69bf-e84e-e063-6294a90aa591 2d918ec8-3098-1d09-e063-6294a90a9e8f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.