Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Childrens Cold Solution
FDA Label NDC 0363-9057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Childrens Cold (NDC 0363-9057). 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
- stuffy nose
- nasal congestion due to a cold
- the intensity of coughing
- 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?
1-800-426-9391
Principal Display Panel
Walgreens
Compare to the active ingredients
in Mucinex® Children’s
Multi-Symptom Cold††
• WALGREENS •
PHARMACIST RECOMMENDED†
MULTI-SYMPTOM
Children’s
Cold
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl /
NASAL DECONGESTANT
ORAL SOLUTION
Alcohol Free
• Relief from: stuffy nose,
cough & chest congestion
• Breaks up mucus
AGES
4-11
YEARS
4 FL OZ (118 mL)
Berry
flavor
†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered
trademark Mucinex® Children’s Multi-Symptom Cold.
50844 ORG022305736
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Walgreens 44-057 (Walgreens 44 057 1)
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