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NDC 00135-0578-01 FLONASE 325; 2; 5 mg/1; mg/1; mg/1 Details
FLONASE 325; 2; 5 mg/1; mg/1; mg/1
FLONASE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; 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: 00135-0578-01Last Updated: 11/30/2022
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: 00135-0578-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 00135-0578-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00135-0578 |
|---|---|
| Product ID | 0135-0578_0a4a4e6d-9f4f-d55b-e063-6394a90ab7eb |
| 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 | FLONASE |
| Proprietary Name Suffix | Headache and Allergy Relief |
| Non-Proprietary Name | acetaminophen, chlorpheniramine maleate, phenylephrine hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 325; 2; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00135-0578-01 (00135057801)
| NDC Package Code | 0135-0578-01 |
|---|---|
| Billing NDC | 00135057801 |
| Package | 1 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2022-03-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |