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NDC 36800-0839-26 topcare childrens mucus relief multi symptom cold 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL Details
topcare childrens mucus relief multi symptom cold 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
topcare childrens mucus relief multi symptom cold is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0839-26Last 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: 36800-0839-26Last 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: 36800-0839-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 36800-0839 |
|---|---|
| Product ID | 36800-839_a03af92b-b719-4cc7-bb02-25ac7c145db2 |
| Associated GPIs | 43997303100960 |
| 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 | topcare childrens mucus relief multi symptom cold |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan HBr, guaifenesin, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| 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 | Topco Associates LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0839-26 (36800083926)
| NDC Package Code | 36800-839-26 |
|---|---|
| Billing NDC | 36800083926 |
| Package | 1 BOTTLE in 1 CARTON (36800-839-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2014-08-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e1662578-63c7-43e9-93f5-4d1603cadc6d 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 giving this product.
Keep out of reach of children.
Directions
- •
- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
- •
- do not use dosing cup with other products
- •
- 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 |
Inactive ingredients
Package/Label Principal Display Panel
COMPARE TO CHILDREN’S MUCINEX® MULTI-SYMPTOM COLD ACTIVE INGREDIENTS
children’s
Multi-Symptom
Cold
Mucus Relief
OUR PHARMACISTS RECOMMEND
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT – PHENYLEPHRINE HCl
Controls Cough
Relieves Chest Congestion
Breaks Up Mucus
Relieves Stuffy Nose
ALCOHOL FREE
Ages 4 to 12 Years
VERY BERRY FLAVOR
4 FL OZ (118mL)
INGREDIENTS AND APPEARANCE
| TOPCARE CHILDRENS MUCUS RELIEF MULTI SYMPTOM COLD
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution |
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| Labeler - Topco Associates LLC (006935977) |