Search by Drug Name or NDC
NDC 48433-0221-40 GUAIFENESIN AND DEXTROMETHORPHAN HBr 10; 100 mg/5mL; mg/5mL Details
GUAIFENESIN AND DEXTROMETHORPHAN HBr 10; 100 mg/5mL; mg/5mL
GUAIFENESIN AND DEXTROMETHORPHAN HBr is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Safecor Health, LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
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: 48433-0221-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 48433-0221-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 48433-0221 |
|---|---|
| Product ID | 48433-221_1d3c7180-99b1-4a08-929d-a4515d977c7a |
| 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 | GUAIFENESIN AND DEXTROMETHORPHAN HBr |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | guaifenesin and dextromethorphan hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Safecor Health, LLC |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 48433-0221-40 (48433022140)
| NDC Package Code | 48433-221-40 |
|---|---|
| Billing NDC | 48433022140 |
| Package | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (48433-221-40) / 5 mL in 1 CUP, UNIT-DOSE (48433-221-05) |
| Marketing Start Date | 2022-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dea4f8c4-0d63-4edc-8e64-ccb8d1241a7d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings:
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.
Do not use if you have ever had an allergic reaction to any of the ingredients in this product.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a Doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Follow dosage below or use as directed by a doctor.
Do not take more than 6 doses in any 24-hour period.
| Age | Dose |
| Adults and children 12 years and over | 10 mL (2 teaspoonfuls) every 4 hours |
| Children 6 years to under 12 years | 5 mL (1 teaspoonful) every 4 hours |
| Children 2 years to under 6 years | 2.5 mL (1/2 teaspoonful) every 4 hours |
| Children under 2 years | ask a doctor |
Other Information:
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
NDC: 48433-221-05 GUAIFENESIN AND DEXTROMETHORPHAN HBr (100 mg / 10 mg per 5 mL) Unit Dose Cup
Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204
Guaifenesin and Dextromethorphan HBr Oral Solution (100 mg / 10 mg per 5 mL) Unit Dose Cup
Rev: 03/2021 PN5713
3 48433 22105 1
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hydrobromide liquid |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - Safecor Health, LLC (828269675) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Safecor Health, LLC | 828269675 | repack(48433-221) | |