FDA.reportPublic FDA data

Daytime and Nighttime Kids' Multi-Symptom Cold & Flu Combo pack

Manufacturer
Genexa Inc.
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-06-03 18:03:29

Label at a glance#

ProductDaytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure23 sections

Storage and handling

Other information store between 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Kids' Nighttime Multi-Symptom Cold & Flu

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 10 mL)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Antihistamine/Cough Suppressant

INDICATIONS & USAGE SECTION

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

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.
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

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).

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

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

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

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 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

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.

SPL UNCLASSIFIED SECTION

Kids' Daytime Multi-Symptom Cold & Flu

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 years10 mL every 4 hours
children 4 to under 6 years7.5 mL every 4 hours
children under 4 yearsdo 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

Distributed by: Genexa Inc.,

Atlanta, GA 30324

genexa.com

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0092-3

RECENT MAJOR CHANGES SECTION

Kids' Nighttime Multi-Symptom Cold & Flu

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMBO PACK

Genexa ®

CLEAN MEDICINE

Kids' Multi-Symptom DAYTIME Cold & Flu

Ages 4+

ACETAMINOPHEN

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Fever, Headache, Sore Throat, Cough, Body Aches & Pains

Kids' Multi-Symptom NIGHTTIME Cold & Flu

Ages 6+

ACETAMINOPHEN

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Fever, Sore Throat, Body Pain, Cough, Runny Nose & Sneezing

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Real Agave + Blueberry Flavoring

TWO - 4 FL OZ (118 mL) BOTTLES

TOTAL - 8 FL OZ (236 mL)

10066-GNX carton_R-2025122610066-GNX carton_R-20251226

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2693776{1 (acetaminophen 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral Suspension) / 1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral Suspension) } PackGPCK6
26937761 daytime (acetaminophen 320 MG / dextromethorphan HBr 5 MG in 10 mL Oral Suspension) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Suspension) PackPSN6
2693770acetaminophen 320 MG / dextromethorphan HBr 5 MG in 10 mL Oral SuspensionPSN6
2693775acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG in 10 mL Oral SuspensionPSN6
2693770acetaminophen 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral SuspensionSCD6
2693775acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SuspensionSCD6
26937761 daytime (acetaminophen 320 MG / dextromethorphan HBr 5 MG per 10 ML Oral Suspension) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG per 10 ML Oral Suspension) PackSY6
2693770acetaminophen 320 MG / dextromethorphan HBr 5 MG per 10 ML Oral SuspensionSY6
2693775acetaminophen 325 MG / diphenhydramine HCl 12.5 MG per 10 mL Oral SuspensionSY6
2693770APAP 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML Oral SuspensionSY6
2693775APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SuspensionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-009269676-0092-3
69676-0096
69676-0091

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
BLUEBERRY253RUG1X1AIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
BLUEBERRY253RUG1X1AIACT
WATER059QF0KO0RIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-02full-release2026-06-01 01:23:07

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
ndc (product): 69676-0096
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
ndc (package): 69676-0092-3
ndc (product): 69676-0092
ndc11 (package): 69676009203
spl id: 52ea76d4-2910-0139-e063-6294a90a3569
spl set id: 213fe898-dace-9a0f-e063-6394a90afd64

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.