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NDC 63824-0591-16 Mucinex Fast-Max 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details
Mucinex Fast-Max 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Mucinex Fast-Max is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63824-0591-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 63824-0591-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 63824-0591-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0591 |
|---|---|
| Product ID | 63824-591_e41aa137-fd0f-fc03-e053-2a95a90a9c4e |
| Associated GPIs | 43998304100120 |
| GCN Sequence Number | 074293 |
| GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG CAPSULE 5-325-200 ORAL |
| HIC3 | B4P |
| HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
| GCN | 38895 |
| HICL Sequence Number | 035445 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Fast-Max |
| Proprietary Name Suffix | Cold, Flu and Sore Throat |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0591-16 (63824059116)
| NDC Package Code | 63824-591-16 |
|---|---|
| Billing NDC | 63824059116 |
| Package | 2 BLISTER PACK in 1 CARTON (63824-591-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2015-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.73688 |
| Pricing Unit | EA |
| Effective Date | 2022-03-23 |
| NDC Description | MUCINEX FAST-MAX COLD-FLU-THRT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 6 |
| Classification for Rate Setting | B |
| As of Date | 2022-06-29 |
Standard Product Labeling (SPL)/Prescribing Information SPL a3523aa3-9ed1-472d-9986-438440d0a3eb Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and older: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton
Fast Dissolving Liquid Gels!
MAXIMUM STRENGTH
NDC 63824-591-16
Mucinex®
FAST-MAX
®
COLD, FLU
& SORE THROAT
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant
- Controls Cough, Thins & Loosens Mucus
- Relieves Nasal & Chest Congestion
- Relieves Headache & Fever
16
LIQUID GELS
(Liquid Filled Capsules)
DAY TIME
FOR AGES 12+
INGREDIENTS AND APPEARANCE
| MUCINEX FAST-MAX
COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled |
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| Labeler - RB Health (US) LLC (081049410) |