![MAXIFED (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MCR AMERICAN PHARMACEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/8a1be614-2a78-4899-9697-774479f2daa5/maxifed-01.jpg)
| NDC | 58605-101-01, 58605-101-20 |
| Set ID | 8a1be614-2a78-4899-9697-774479f2daa5 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MCR American Pharmaceuticals, Inc. |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
- Do not exceed recommended dosage.
- a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
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Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: ½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age consult a doctor - Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 360 mg/60 mg Tablet Bottle Label
NDC 58605-101-01
100 tabletsMaxifed
Expectorant • Nasal Decongestant
Each immediate-release tablet contains:
Guaifenesin 360 mg
Pseudoephedrine HCl 60 mgStore at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap. Do not use if foil seal is broken
or missing.
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INGREDIENTS AND APPEARANCE
MAXIFED
guaifenesin and pseudoephedrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58605-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 360 mg Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 60 mg Inactive Ingredients Ingredient Name Strength Magnesium Stearate (UNII: 70097M6I30) Microcrystalline Cellulose (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code MAXIFED Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58605-101-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2018 2 NDC:58605-101-20 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2018 Labeler - MCR American Pharmaceuticals, Inc. (783383011) Establishment Name Address ID/FEI Business Operations MCR American Pharmaceuticals, Inc. 783383011 MANUFACTURE(58605-101)