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NDC 63824-0555-30 Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Details
Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu
Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is .
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: 63824-0555-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 63824-0555-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 63824-0555-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 63824-0555-30Last 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: 63824-0555-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0555 |
|---|---|
| Product ID | 63824-555_85084eef-ac73-450f-a42f-78364bc7456c |
| Associated GPIs | 43998805406330 |
| GCN Sequence Number | 073531 |
| GCN Sequence Number Description | diphenhydram/PE/DM/acetamin/GG TABLET SEQ 25-5-325MG ORAL |
| HIC3 | B4O |
| HIC3 Description | NON-OPIOID ANTITUS-1ST ANTIHIST-DECON-ANALG-EXPECT |
| GCN | 37839 |
| HICL Sequence Number | 036616 |
| HICL Sequence Number Description | DIPHENHYDRAMINE/PHENYLEPHRIN/DEXTROMETHORPH/ACETAMINOPHEN/GG |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu |
| Proprietary Name Suffix | Maximum Strength |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, and Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63824-0555-30 (63824055530)
| NDC Package Code | 63824-555-30 |
|---|---|
| Billing NDC | 63824055530 |
| Package | 1 KIT in 1 CARTON (63824-555-30) * 10 TABLET, COATED in 1 BLISTER PACK * 10 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2014-04-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 815f0ec8-d89d-4e74-8328-5e3b30fbe3ec Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves (DAY TIME only):
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
- nasal congestion
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing
- temporarily reduces fever (NIGHT TIME only)
- controls cough to help you get to sleep
Warnings
Liver warning (NIGHT TIME only)
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs that contain acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning (NIGHT TIME only): 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. (NIGHT TIME only)
- with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
- 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease (NIGHT TIME only)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME only)
- cough that occurs with too much phlegm (mucus) (DAY TIME only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin (NIGHT TIME only)
- taking sedatives or tranquilizers (NIGHT TIME only)
When using this product do not use more than directed. In addition, for NIGHT TIME only:
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with a fever (DAY TIME only)
- pain, nasal congestion, or cough gets worse, or lasts more than 7 days (NIGHT TIME only)
- fever gets worse, or lasts more than 3 days (NIGHT TIME only)
- redness or swelling is present (NIGHT TIME only)
- new symptoms occur (NIGHT TIME only)
- cough comes back, or occurs with fever, 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 caplets in any 24-hour period
- adults and children 12 years of age and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Inactive ingredients (Mucinex FAST-MAX DAY TIME Severe Congestion & Cough)
Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu)
PRINCIPAL DISPLAY PANEL - Kit Carton
MAXIMUM STRENGTH*
NDC 63824-555-30
Mucinex®
FAST-MAX®
DAY
TIME
Severe Congestion
& Cough
Dextromethorphan HBr • Cough Suppressant
Guaifenesin • Expectorant
Phenylephrine HCl • Nasal Decongestant
✓ Controls Cough
✓ Relieves Nasal &
Chest Congestion
✓ Thins & Loosens Mucus
AGES 12+
20 CAPLETS
NIGHT
TIME
Cold & Flu
Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine
Phenylephrine HCl • Nasal Decongestant
✓ Relieves Aches,
Fever & Sore Throat
✓ Relieves Nasal Congestion
✓ Relieves Runny Nose
& Sneezing
10 CAPLETS
INGREDIENTS AND APPEARANCE
| MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU
MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine hydrochloride kit |
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| Labeler - RB Health (US) LLC (081049410) |