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NDC 76281-0307-25 XL-3 Xtreme 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL Details
XL-3 Xtreme 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
XL-3 Xtreme is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. 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: 76281-0307-25Last 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: 76281-0307-25Last 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: 76281-0307-25Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 76281-0307 |
|---|---|
| Product ID | 76281-307_95f58511-c4d4-4a9d-b8be-ba0b464f2e59 |
| 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 | XL-3 Xtreme |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| 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 | AptaPharma Inc. |
| 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 DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76281-0307-25 (76281030725)
| NDC Package Code | 76281-307-25 |
|---|---|
| Billing NDC | 76281030725 |
| Package | 177 mL in 1 BOTTLE (76281-307-25) |
| Marketing Start Date | 2018-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |