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NDC 00904-6763-20 robafen 200 mg/10mL Details
robafen 200 mg/10mL
robafen is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is GUAIFENESIN.
MedlinePlus Drug Summary
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: 00904-6763-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 00904-6763 |
|---|---|
| Product ID | 0904-6763_2c946d4b-760f-49e7-a3ec-367b24fbeb22 |
| Associated GPIs | 43200010001210 43200010000910 |
| GCN Sequence Number | 022210 |
| GCN Sequence Number Description | guaifenesin LIQUID 100 MG/5ML ORAL |
| HIC3 | B3J |
| HIC3 Description | EXPECTORANTS |
| GCN | 02512 |
| HICL Sequence Number | 000271 |
| HICL Sequence Number Description | GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | robafen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/10mL |
| Substance Name | GUAIFENESIN |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-6763-20 (00904676320)
| NDC Package Code | 0904-6763-20 |
|---|---|
| Billing NDC | 00904676320 |
| Package | 1 BOTTLE in 1 CARTON (0904-6763-20) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-08-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.02001 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | ROBAFEN 200 MG/10 ML SYRUP |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 25f18a65-6b39-4e0a-8bae-79d2eac5abb1 Details
Warnings
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
Directions
- •
- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
- •
- keep dosing cup with product
- •
- mL = milliliter
- •
- this adult product is not intended for use in children under 12 years of age
|
age |
dose |
|
adults and children 12 years and over |
10 – 20 mL every 4 hours |
|
children under 12 years |
do not use |
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| ROBAFEN
guaifenesin solution |
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| Labeler - Major Pharmaceuticals (191427277) |
Revised: 10/2021
Document Id: 2c946d4b-760f-49e7-a3ec-367b24fbeb22
Set id: 25f18a65-6b39-4e0a-8bae-79d2eac5abb1
Version: 5
Effective Time: 20211019