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NDC 81522-0898-16 Daytime Cold and Flu 325; 10; 5 mg/1; mg/1; mg/1 Details
Daytime Cold and Flu 325; 10; 5 mg/1; mg/1; mg/1
Daytime Cold and Flu is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc. (Caring Mills). The primary component is ACETAMINOPHEN; 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: 81522-0898-16Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Acetaminophen
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: 81522-0898-16Last Updated: 02/19/2023
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: 81522-0898-16Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 81522-0898 |
|---|---|
| Product ID | 81522-898_42d8b4cb-6945-465e-b903-e5818d95c295 |
| 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 | Daytime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | FSA Store Inc. (Caring Mills) |
| 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
NDC 81522-0898-16 (81522089816)
| NDC Package Code | 81522-898-16 |
|---|---|
| Billing NDC | 81522089816 |
| Package | 16 BLISTER PACK in 1 CARTON (81522-898-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2022-11-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |