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NDC 70677-0110-01 Guaifenesin and Pseudoephedrine HCl 600; 60 mg/1; mg/1 Details
Guaifenesin and Pseudoephedrine HCl 600; 60 mg/1; mg/1
Guaifenesin and Pseudoephedrine HCl is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services, LLC. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.
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: 70677-0110-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 70677-0110-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 70677-0110 |
|---|---|
| Product ID | 70677-0110_9e566f31-286f-594b-84de-83414176390a |
| Associated GPIs | |
| GCN Sequence Number | 012073 |
| GCN Sequence Number Description | guaifenesin/pseudoephedrne HCl TAB ER 12H 600MG-60MG ORAL |
| HIC3 | B4W |
| HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
| GCN | 54980 |
| HICL Sequence Number | 000270 |
| HICL Sequence Number Description | GUAIFENESIN/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Guaifenesin and Pseudoephedrine HCl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Pseudoephedrine HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 600; 60 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services, LLC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208369 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70677-0110-01 (70677011001)
| NDC Package Code | 70677-0110-1 |
|---|---|
| Billing NDC | 70677011001 |
| Package | 1 BLISTER PACK in 1 CARTON (70677-0110-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2020-07-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.38044 |
| Pricing Unit | EA |
| Effective Date | 2022-11-23 |
| NDC Description | SM GUAIFENESIN-PSE ER 600-60 |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |