FDA Label for Mucinex Childrens Cough And Chest Congestion Mini-melts Orange Creme
View Indications, Usage & Precautions
Mucinex Childrens Cough And Chest Congestion Mini-melts Orange Creme Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Dist. By: RB Health (US)
Parsippany, NJ 07054-0224
Made in Germany
Otc - Purpose
| 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.
Otc - Do Not Use
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 that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Otc - When Using
When using this product do not use more than directed
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 give 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
You may also report side effects to this phone number.
Principal Display Panel - 12 Packet Carton
Pediatrician Recommended*
NDC 63824-943-12
Mucinex®
children's
COUGH AND
CHEST CONGESTION
Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
✓ Controls Cough✓ Relieves Chest Congestion✓ Thins and Loosens Mucus
Ages
4+ years
Orange Crème
Flavor
12 GRANULE PACKETS
* Please review the disclaimer below.