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NDC 58552-0131-04 Giltuss Childrens Cough and Cold 7.5; 150; 5 mg/2.5mL; mg/2.5mL; mg/2.5mL Details
Giltuss Childrens Cough and Cold 7.5; 150; 5 mg/2.5mL; mg/2.5mL; mg/2.5mL
Giltuss Childrens Cough and Cold is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Gil Pharmaceutical Corp. 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: 58552-0131-04Last Updated: 12/01/2022
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: 58552-0131-04Last Updated: 12/01/2022
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: 58552-0131-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 58552-0131 |
|---|---|
| Product ID | 58552-131_0874f27e-12f4-aacf-e063-6294a90acccd |
| Associated GPIs | 43997303100930 |
| GCN Sequence Number | 040291 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 300-15-10 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 53093 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Brand |
| Proprietary Name | Giltuss Childrens Cough and Cold |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 7.5; 150; 5 |
| Active Ingredient Units | mg/2.5mL; mg/2.5mL; mg/2.5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Gil Pharmaceutical Corp |
| 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 DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58552-0131-04 (58552013104)
| NDC Package Code | 58552-131-04 |
|---|---|
| Billing NDC | 58552013104 |
| Package | 1 BOTTLE in 1 CARTON (58552-131-04) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-11-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |