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NDC 50383-0063-18 Guaifenesin 100 mg/5mL Details
Guaifenesin 100 mg/5mL
Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. 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: 50383-0063-18Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 50383-0063 |
|---|---|
| Product ID | 50383-063_2651ad0c-0f3f-44e2-8273-d480d6f50ecc |
| Associated GPIs | 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 | Guaifenesin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | GUAIFENESIN |
| Labeler Name | Akorn |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0063-18 (50383006318)
| NDC Package Code | 50383-063-18 |
|---|---|
| Billing NDC | 50383006318 |
| Package | 10 TRAY in 1 CASE (50383-063-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE |
| Marketing Start Date | 2012-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5cb704a7-301c-494e-948f-872ee0d5a289 Details
Active ingredient
Inactive ingredients
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
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.
- •
- you are hypersensitive to any of the ingredients
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Directions
Follow dosage below or use as directed by a physician.
- •
- do not take more than 6 doses in any 24-hour period
|
age |
dose |
|
adults and children 12 years and over |
10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours |
|
children 6 years to under 12 years |
5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours |
|
children 2 to under 6 years of age |
2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours |
|
children under 2 years of age |
ask a doctor |
How Supplied:
Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
STORAGE
Questions or comments?
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| GUAIFENESIN
guaifenesin solution |
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| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Compnay LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-063) , PACK(50383-063) | |