Storage and handling
Other information store between 20-25°C (68-77°F)
Kids Cough Daytime Nighttime Combo
- Manufacturer
- Genexa Inc.
- Effective date
- 2024-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:19
Label at a glance#
ProductKids Cough Daytime Nighttime Combo
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE
Label structure23 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Kids' Cough & Chest Congestion
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL)
Dextromethorphan HBr, 5 mg
Guaifenesin, USP 100 mg
OTC - PURPOSE SECTION
Purposes
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
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use 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
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
OTC - STOP USE SECTION
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions
- SHAKE WELL before each use
- do not give more than 6 doses in any 24-hour period
- use only with enclosed dose cup. Do not use with any other dosing device.
- mL = milliliter
| Age | Dose |
| children 6 to under 12 years | 5 mL - 10 mL every 4 hours |
| children 4 to under 6 years | 2.5 mL - 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
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.
SPL UNCLASSIFIED SECTION
Kids' Nighttime Cough
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each 10 mL)
Chlorpheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 15 mg
OTC - PURPOSE SECTION
Purposes
Antihistamine
Cough suppressant
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes
• itching of the nose or throat
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use
• to sedate a child or make a child sleepy
• if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
•
Do not use more than directed
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
OTC - STOP USE SECTION
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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).
DOSAGE & ADMINISTRATION SECTION
Directions
- SHAKE WELL before each use.
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- do not take more than 4 doses in any 24-hour period
| Age | Dose |
Adults and children 12 years and older | 20 mL every 6 hours |
Children 6 to under 12 years | 10 mL every 6 hours |
| Children under 6 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
**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Nighttime Cough Long-Acting DM.
SPL UNCLASSIFIED SECTION
SHAKE WELL before each use.
Bottles are safety sealed with a perforated band around bottles. DO NOT use if bottle seals are disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30324 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0090-9
RECENT MAJOR CHANGES SECTION
Kids' Cough & Chest Congestion
Directions
SHAKE WELL before each use.
do not give more than 6 doses in any 24-hour period
use only with enclosed dose cup. Do not use with any other dosing device.
mL = milliliter
| Age | Dose |
| children 6 to under 12 years | 5 mL - 10 mL every 4 hours |
| children 4 to under 6 years | 2.5 mL - 5 mL every 4 hours |
| children under 4 years | do not use |
Kids' Nighttime Cough
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes
• itching of the nose or throat
Directions
SHAKE WELL before each use.
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
do not take more than 4 doses in any 24-hour period
| Age | Dose |
Adults and children 12 years and older | 20 mL every 6 hours |
Children 6 to under 12 years | 10 mL every 6 hours |
| Children under 6 years | do not use |
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DAYTIME + NIGHTTIME VALUE PACK
Genexa®
MEDICINE MADE CLEAN
Ages 4+
Kids' Cough & Chest Congestion
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Cough
Mucus
Chest Congestion
Made with the same active ingredients as Children's Robitussin® Cough & Chest Congestion DM*
Medicine made clean
Same effective active ingredients, but no artificial fillers.
Organic Blueberry Flavor
4 fl oz (118 mL)
Dosing cup included
Ages 6+
Long-Acting
Kids' Nighttime Cough
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Relieves Cough up to 8 Hours
Runny Nose
Sneezing
Made with the same active ingredients as Children's Robitussin® Nighttime Cough Long-Acting DM**
Medicine made clean
Same effective active ingredients, but no artificial fillers.
Organic Blueberry Flavor
4 fl oz (118 mL)
Dosing cup included
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2119625 | {1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } Pack | GPCK | 2 |
| 2119625 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) Pack | PSN | 2 |
| 1111440 | chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution | PSN | 2 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 2 |
| 1111440 | chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution | SCD | 2 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2 |
| 2119625 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) Pack | SY | 2 |
| 1111440 | chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution | SY | 2 |
| 1111440 | chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution | SY | 2 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 2 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0090-9 | Kids Cough Daytime Nighttime Combo | 1 in 1 KIT | KIT | 1 | 2 | |
| 69676-0090-9 | Kids Cough Daytime Nighttime Combo | 1 in 1 BOTTLE | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0090 | KIDS COUGH DAYTIME NIGHTTIME COMBO (DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE) KIT [GENEXA INC.] | 2 | 2 package rows | 20240207_036fb529-3270-c649-e063-6394a90a2d74.zip |
Products#
Every source-derived product name is available through these pages.
- Kids Cough Daytime Nighttime Combo
- Dextromethorphan HBr, Guaifenesin, Chlorpheniramine Maleate
- Kids Cough and Chest Congestion
- Dextromethorphan HBr, Guaifenesin
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CITRUS FRUIT
- GUAIFENESIN
- AGAVE TEQUILANA STEM
- Nighttime Cough-Kids
- Chlorpheniramine Maleate, Dextromethorphan HBr
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0090 | 69676-0090-9 |
| 69676-0037 | |
| 69676-0088 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CITRUS FRUIT | XDK00Z8012 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| AGAVE TEQUILANA STEM | J026JA743Y | IACT |
| CITRUS FRUIT | XDK00Z8012 | IACT |
| WATER | 059QF0KO0R | IACT |
| AGAVE TEQUILANA STEM | J026JA743Y | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
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 Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | a7ab2140-de09-158f-e053-2a95a90a25a0 | 2026-05-28 | Warnings | 69676-0037 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | 69676-0088 |
| 10bc87d5-6e0f-e260-e063-6294a90a5cb5 | 036fb529-3270-c649-e063-6394a90a2d74 | 2024-02-06 | Warnings | 10bc87d5-6e0f-e260-e063-6294a90a5cb5 036fb529-3270-c649-e063-6394a90a2d74 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.