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NDC 58552-0137-04 Giltuss Childrens MultiSymptom Cold and Flu 325; 2; 6.5; 5 mg/5mL; mg/5mL; mg/5mL; mg/5mL Details
Giltuss Childrens MultiSymptom Cold and Flu 325; 2; 6.5; 5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Giltuss Childrens MultiSymptom Cold and Flu is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Giltuss Pharmaceutical Corp. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 58552-0137-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 58552-0137-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 58552-0137-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 58552-0137-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 58552-0137 |
|---|---|
| Product ID | 58552-137_0874fce4-0e32-ed3b-e063-6294a90adb7a |
| Associated GPIs | 43995904160935 |
| GCN Sequence Number | 080850 |
| GCN Sequence Number Description | DM/pe/acetaminophen/chlorphenr LIQUID 10-650/10 ORAL |
| HIC3 | B3P |
| HIC3 Description | NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC |
| GCN | 47832 |
| HICL Sequence Number | 000372 |
| HICL Sequence Number Description | DEXTROMETHORPHAN/PHENYLEPHRINE/ACETAMINOPHEN/CHLORPHENIRAMIN |
| Brand/Generic | Brand |
| Proprietary Name | Giltuss Childrens MultiSymptom Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 2; 6.5; 5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL; mg/5mL |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Giltuss Pharmaceutical Corp |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58552-0137-04 (58552013704)
| NDC Package Code | 58552-137-04 |
|---|---|
| Billing NDC | 58552013704 |
| Package | 1 BOTTLE in 1 CARTON (58552-137-04) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-10-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |