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NDC 70000-0183-01 Leader Nighttime Cold and Flu 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL Details
Leader Nighttime Cold and Flu 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Leader Nighttime 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; DOXYLAMINE SUCCINATE.
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: 70000-0183-01Last 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: 70000-0183-01Last Updated: 12/01/2022
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: 70000-0183-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 70000-0183 |
|---|---|
| Product ID | 70000-0183_a179ec7e-a683-4741-b016-171bd0f1e5f4 |
| Associated GPIs | 43998903350918 |
| GCN Sequence Number | 067635 |
| GCN Sequence Number Description | DM/acetaminophen/doxylamine LIQUID 15-325/15 ORAL |
| HIC3 | B4G |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB |
| GCN | 30232 |
| HICL Sequence Number | 025663 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/ACETAMINOPHEN/DOXYLAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Leader Nighttime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Doxylamine succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 30; 12.5 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70000-0183-01 (70000018301)
| NDC Package Code | 70000-0183-1 |
|---|---|
| Billing NDC | 70000018301 |
| Package | 355 mL in 1 BOTTLE (70000-0183-1) |
| Marketing Start Date | 2016-11-16 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.00938 |
| Pricing Unit | ML |
| Effective Date | 2022-02-23 |
| NDC Description | NIGHTTIME COLD AND FLU LIQUID |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-03-16 |