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NDC 00280-0021-01 Alka-Seltzer Plus Severe Cold Powerfast Fizz Night 500; 10; 6.25; 7.8 mg/1; mg/1; mg/1; mg/1 Details
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night 500; 10; 6.25; 7.8 mg/1; mg/1; mg/1; mg/1
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by Bayer HealthCare LLC.. The primary component is ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE.
MedlinePlus Drug Summary
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.
Related Packages: 00280-0021-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin
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: 00280-0021-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 00280-0021-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
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: 00280-0021-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00280-0021 |
|---|---|
| Product ID | 0280-0021_0bb5cfdb-9b12-e451-e063-6394a90afefc |
| 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 | Alka-Seltzer Plus Severe Cold Powerfast Fizz Night |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EFFERVESCENT |
| Route | ORAL |
| Active Ingredient Strength | 500; 10; 6.25; 7.8 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE |
| Labeler Name | Bayer HealthCare LLC. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonst |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00280-0021-01 (00280002101)
| NDC Package Code | 0280-0021-01 |
|---|---|
| Billing NDC | 00280002101 |
| Package | 10 POUCH in 1 CARTON (0280-0021-01) / 2 TABLET, EFFERVESCENT in 1 POUCH |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |