Search by Drug Name or NDC
NDC 55505-0190-36 Safetussin 7.5; 3.125 mg/5mL; mg/5mL Details
Safetussin 7.5; 3.125 mg/5mL; mg/5mL
Safetussin is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Laboratories. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.
MedlinePlus Drug Summary
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: 55505-0190-36Last 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: 55505-0190-36Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 55505-0190 |
|---|---|
| Product ID | 55505-190_f68e2d21-632b-4e9f-ab3f-5c6dea20db0c |
| 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 | Safetussin |
| Proprietary Name Suffix | PM |
| Non-Proprietary Name | Dextromethorphan Doxylamine Succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 7.5; 3.125 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Labeler Name | Kramer Laboratories |
| 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 | 2023-12-31 |
Package
Package Images
NDC 55505-0190-36 (55505019036)
| NDC Package Code | 55505-190-36 |
|---|---|
| Billing NDC | 55505019036 |
| Package | 240 mL in 1 BOTTLE, PLASTIC (55505-190-36) |
| Marketing Start Date | 2015-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL da5c218f-685c-4862-b532-9b525259663b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep.
INGREDIENTS AND APPEARANCE
| SAFETUSSIN
PM
dextromethorphan doxylamine succinate liquid |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - Kramer Laboratories (122720675) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Denison Pharmecuticals | 001207208 | manufacture(55505-190) | |