Indications and uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves cough as may occur with a cold.
Mucinex Childrens
- Manufacturer
- RB Health (US) LLC
- Effective date
- 2021-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:20:48
Label at a glance#
ProductMucinex Childrens Cough Mini-Melts Orange Creme
Active ingredientDextromethorphan Hydrobromide, Guaifenesin
Label structure10 sections
Dosage and administration
empty entire contents of packet onto tongue and swallow for best taste, do not chew granules do not take more than 6 doses in any 24-hour period dose as follows or as directed by a doctor Age Dose adults and children 12 years of age and over 2 to 4 packets every 4 hours children 6 years to under 12 years of age 1 to 2 packets every 4 hours children 4 years to under 6 years of age 1 packet every 4 hours children un...
Storage and handling
each packet contains: magnesium 6 mg and sodium 3 mg phenylketonurics : contains phenylalanine 2 mg per packet store at 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each packet) | Purposes |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves cough as may occur with a cold.
Warnings
OTC - DO NOT USE SECTION
Do not use 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.
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
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 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 - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a healthcare 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.
Directions
- empty entire contents of packet onto tongue and swallow
- for best taste, do not chew granules
- do not take more than 6 doses in any 24-hour period
- dose as follows or as directed by a doctor
| Age | Dose |
|---|---|
| adults and children 12 years of age and over | 2 to 4 packets every 4 hours |
| children 6 years to under 12 years of age | 1 to 2 packets every 4 hours |
| children 4 years to under 6 years of age | 1 packet every 4 hours |
| children under 4 years of age | do not use |
Other information
- each packet contains: magnesium 6 mg and sodium 3 mg
- phenylketonurics: contains phenylalanine 2 mg per packet
- store at 20-25°C (68-77°F)
Inactive ingredients
aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate
Questions?
1-866-682-4639
SPL UNCLASSIFIED SECTION
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in Germany
PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton
Pediatrician Recommended*
NDC 63824-942-31
Mucinex®
Children's
COUGH
Dextromethorphan HBr 5 mg – Cough Suppressant
Guaifenesin 100 mg – Expectorant
✓ Controls Cough
✓ Relieves Chest Congestion
✓ Breaks up Mucus
Ages
4+
years
Orange Creme
Flavor
12 GRANULE PACKETS
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-942-31 | EA - Each | 63824-942 | 6408e524-9604-4598-afa1-ee0a246a05f1 | 1 | 2020-03-10 |
Products#
Every source-derived product name is available through these pages.
- Mucinex Childrens Cough Mini-Melts Orange Creme
- Dextromethorphan Hydrobromide and Guaifenesin
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Guaifenesin
- ASPARTAME
- CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- SODIUM BICARBONATE
- SORBITOL
- STEARIC ACID
- TALC
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-942 | 63824-942-31, 63824-942-02, 63824-942-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 45ab0502-ae94-434f-a8ef-cbcd47732f6b | f572a46a-4852-4b1f-9d4e-e08e432b9ce2 | 2021-12-22 | Warnings | 45ab0502-ae94-434f-a8ef-cbcd47732f6b f572a46a-4852-4b1f-9d4e-e08e432b9ce2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.