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NDC 00067-6095-01 THERAFLU 650; 25; 10 mg/1; mg/1; mg/1 Details
THERAFLU 650; 25; 10 mg/1; mg/1; mg/1
THERAFLU is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00067-6095-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 00067-6095-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 00067-6095-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-6095 |
|---|---|
| Product ID | 0067-6095_6aaf7108-4983-4951-901e-11bc65ccc933 |
| Associated GPIs | 43994003906330 |
| GCN Sequence Number | 079605 |
| GCN Sequence Number Description | diphenhyd/phenyleph/acetaminop POWDER POD 25-10-650 ORAL |
| HIC3 | B3O |
| HIC3 Description | 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB |
| GCN | 46137 |
| HICL Sequence Number | 035433 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | THERAFLU |
| Proprietary Name Suffix | POWERPODS NIGHTTIME SEVERE COLD |
| Non-Proprietary Name | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 25; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00067-6095-01 (00067609501)
| NDC Package Code | 0067-6095-01 |
|---|---|
| Billing NDC | 00067609501 |
| Package | 8 POUCH in 1 CARTON (0067-6095-01) / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6095-02) |
| Marketing Start Date | 2018-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |