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NDC 00363-0512-06 Mucus Congestion and Cough Relief 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL Details
Mucus Congestion and Cough Relief 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
Mucus Congestion and Cough Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 00363-0512-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 00363-0512-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00363-0512-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-0512 |
|---|---|
| Product ID | 0363-0512_08baa37a-3123-47b8-801a-8afb87a574b6 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Mucus Congestion and Cough Relief |
| Proprietary Name Suffix | Childrens |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifensin, Phenylephrine HCI |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5; 100; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Walgreens |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-0512-06 (00363051206)
| NDC Package Code | 0363-0512-06 |
|---|---|
| Billing NDC | 00363051206 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (0363-0512-06) / 201 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2016-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 19cd2409-d56b-4319-833c-eacc7dc498c1 Details
Active ingredients (in each 5 mL)
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
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Warnings
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 taking this product.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Directions
- do not take more than 6 doses in any 24-hour period
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- keep dosing cup with product
- dose as follows or as directed by a doctor
- mL = milliliter
| age | dose |
| children 6 years to under 12 years | 10 mL every 4 hours |
| children 4 years to under 6 years | 5 mL every 4 hours |
| children under 4 years | do not use |
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Congestion & Cough††
Children's
Mucus Congestion & Cough Relief
DEXTROMETHORPHAN HBr 5 mg /
COUGH SUPPRESSANT
GUAIFENESIN 100 mg /
EXPECTORANT
PHENYLEPHRINE HCI 2.5 mg /
NASAL DECONGESTANT
Alcohol Free
- Relief from chest congestion, cough & stuffy nose
- Breaks up mucus
AGES 4 - 11 YEARS
Berry flavor
DOSAGE CUP PROVIDED
FL OZ (mL)
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Congestion & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
INGREDIENTS AND APPEARANCE
| MUCUS CONGESTION AND COUGH RELIEF
CHILDRENS
dextromethorphan hbr, guaifensin, phenylephrine hci liquid |
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| Labeler - Walgreens (008965063) |