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NDC 00573-2952-20 PRIMATENE 12.5; 200 mg/1; mg/1 Details
PRIMATENE 12.5; 200 mg/1; mg/1
PRIMATENE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is EPHEDRINE HYDROCHLORIDE; GUAIFENESIN.
Product Information
| NDC | 00573-2952 |
|---|---|
| Product ID | 0573-2952_c9baccdd-f72e-4461-b87f-bb220754610b |
| Associated GPIs | 43996202050320 |
| GCN Sequence Number | 027149 |
| GCN Sequence Number Description | guaifenesin/ephedrine HCl TABLET 200-12.5MG ORAL |
| HIC3 | B4W |
| HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
| GCN | 53763 |
| HICL Sequence Number | 000238 |
| HICL Sequence Number Description | GUAIFENESIN/EPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | PRIMATENE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ephedrine HCl, guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | EPHEDRINE HYDROCHLORIDE; GUAIFENESIN |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 00573-2952-20 (00573295220)
| NDC Package Code | 0573-2952-20 |
|---|---|
| Billing NDC | 00573295220 |
| Package | 5 BLISTER PACK in 1 CARTON (0573-2952-20) / 12 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2004-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9005482c-25ae-d365-33d1-29269532c74d Details
USES
WARNINGS
Asthma alert
Because asthma may be life threatening, see a doctor if you
- •
- are not better in 60 minutes
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- get worse
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- need more than 12 tablets in 24 hours
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- use more than 8 tablets in 24 hours for 3 or more days a week
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- have more than 2 asthma attacks in a week
These may be signs that your asthma is getting worse
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- This product will not give you asthma relief as quickly as an inhaled bronchodilator
Do not use
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- unless a doctor said you have asthma
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- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- ever been hospitalized for asthma
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- heart disease
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- high blood pressure
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- diabetes
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- thyroid disease
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- seizures
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- narrow angle glaucoma
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- a psychiatric or emotional condition
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
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- taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
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- taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)
Stop use and ask a doctor if
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- your asthma is getting worse (see Asthma alert)
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- you have difficulty sleeping
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- you have a rapid heart beat
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- you have tremors, nervousness, or seizure
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- 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.
When using this product
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- your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
- •
-
your risk of heart attack or stroke increases if you:
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- have a history of high blood pressure or heart disease
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- take this product more frequently or take more than the recommended dose
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- avoid foods or beverages that contain caffeine
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- avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect
DIRECTIONS
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| PRIMATENE
ephedrine hcl, guaifenesin tablet |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Wyeth Pharmaceuticals Company | 829390975 | ANALYSIS(0573-2952) , LABEL(0573-2952) , MANUFACTURE(0573-2952) , PACK(0573-2952) | |
Revised: 6/2021
Document Id: c9baccdd-f72e-4461-b87f-bb220754610b
Set id: 9005482c-25ae-d365-33d1-29269532c74d
Version: 7
Effective Time: 20210625