Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Mucus Relief Solution
FDA Label NDC 76162-057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Mucus Relief (NDC 76162-057). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purpose, uses, do not use, ask a doctor before use if the child has, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Nasal decongestant
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 due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- nasal congestion due to a cold
- the intensity of coughing
- stuffy nose
- the impulse to cough to help the child get to sleep
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.
Ask A Doctor Before Use If The Child Has
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- dose as follows or as directed by a doctor
| Age | Dose |
| children 6 to under 12 years | 10 mL every 4 hours |
| children 4 to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare®
health
NDC 76162-057-88
COMPARE TO MUCINEX®
CHILDREN’S MULTI-SYMPTOM COLD
ACTIVE INGREDIENTS*
children's
Multi-Symptom
Cold
Mucus
Relief
DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
GUAIFENESIN - EXPECTORANT
PHENYLEPHRINE HCl - NASAL DECONGESTANT
ORAL SOLUTION
• Controls Cough
• Relieves Chest Congestion
• Breaks Up Mucus
• Relieves
Stuffy Nose
Ages 4
to
11 Years
BERRY
FLAVOR
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO LNKA0923
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com
*This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Mucinex® Children’s Multi-Symptom Cold.
50844 ORG022305788
Topcare 44-057 (Topcare 44 057 1)
* Please review the disclaimer below.
