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NDC 70000-0191-01 Leader Daytime Cold and Flu 325; 10; 5 mg/15mL; mg/15mL; mg/15mL Details
Leader Daytime Cold and Flu 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Leader Daytime Cold and Flu is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0191-01Last Updated: 12/01/2022
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: 70000-0191-01Last 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: 70000-0191-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 70000-0191 |
|---|---|
| Product ID | 70000-0191_458017fe-13e5-48e3-9a79-7a4b45283645 |
| Associated GPIs | 43996903400910 |
| GCN Sequence Number | 061337 |
| GCN Sequence Number Description | d-methorphan/PE/acetaminophen LIQUID 5-325MG/15 ORAL |
| HIC3 | B4M |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB |
| GCN | 97129 |
| HICL Sequence Number | 008885 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Leader Daytime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen, dextromethorphan Hbr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5 |
| Active Ingredient Units | mg/15mL; mg/15mL; mg/15mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| 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 70000-0191-01 (70000019101)
| NDC Package Code | 70000-0191-1 |
|---|---|
| Billing NDC | 70000019101 |
| Package | 237 mL in 1 BOTTLE (70000-0191-1) |
| Marketing Start Date | 2016-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01263 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | DAYTIME COLD-FLU RELIEF LIQUID |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |