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NDC 50991-0626-02 Poly Hist Forte 10.5; 10 mg/1; mg/1 Details
Poly Hist Forte 10.5; 10 mg/1; mg/1
Poly Hist Forte is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 50991-0626-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 50991-0626-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50991-0626 |
|---|---|
| Product ID | 50991-626_f4c8866f-be6d-304b-e053-2995a90aca55 |
| Associated GPIs | 43993002930325 |
| GCN Sequence Number | 079894 |
| GCN Sequence Number Description | doxylamine/phenylephrine HCl TABLET 10.5-10 MG ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 46499 |
| HICL Sequence Number | 040737 |
| HICL Sequence Number Description | DOXYLAMINE SUCCINATE/PHENYLEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Poly Hist Forte |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Doxylamine Succinate and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10.5; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Poly Pharmaceuticals, Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50991-0626-02 (50991062602)
| NDC Package Code | 50991-626-02 |
|---|---|
| Billing NDC | 50991062602 |
| Package | 12 BLISTER PACK in 1 CARTON (50991-626-02) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2019-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |