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NDC 63824-0519-48 Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Details
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night 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: 63824-0519-48Last 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: 63824-0519-48Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 63824-0519-48Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
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: 63824-0519-48Last 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: 63824-0519-48Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0519 |
|---|---|
| Product ID | 63824-519_deab8320-be58-ae3c-e053-2a95a90a253e |
| Associated GPIs | 4399880550B220 |
| GCN Sequence Number | 074312 |
| GCN Sequence Number Description | doxylam/PE/DM/acetaminophen/GG CAP SEQ 5-10-325MG ORAL |
| HIC3 | B4O |
| HIC3 Description | NON-OPIOID ANTITUS-1ST ANTIHIST-DECON-ANALG-EXPECT |
| GCN | 38925 |
| HICL Sequence Number | 040604 |
| HICL Sequence Number Description | DOXYLAMINE/PHENYLEPHRINE/DEXTROMETHORPHAN/ACETAMINOPHEN/GG |
| Brand/Generic | Brand |
| Proprietary Name | Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, and Phenylephrine 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 | 2024-12-31 |
Package
Package Images
NDC 63824-0519-48 (63824051948)
| NDC Package Code | 63824-519-48 |
|---|---|
| Billing NDC | 63824051948 |
| Package | 2 KIT in 1 CARTON (63824-519-48) / 1 KIT in 1 KIT * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2018-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 19da539e-7b57-41d7-aad5-fc89a6705e20 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- sinus congestion and pressure
- cough
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose (NIGHT only)
- sneezing (NIGHT only)
- itching of the nose or throat (NIGHT only)
- itchy, watery eyes due to hay fever (NIGHT only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
- controls cough to help you get to sleep
- temporarily reduces fever
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
- glaucoma (NIGHT only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NIGHT only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT only)
- marked drowsiness may occur (NIGHT only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
- avoid alcoholic drinks (NIGHT only)
- be careful when driving a motor vehicle or operating machinery (NIGHT only)
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 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 liquid gels in any 24-hour period
- adults and children 12 years of age and over: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
Inactive ingredients (DAY only)
Inactive ingredients (NIGHT only)
PRINCIPAL DISPLAY PANEL - Kit Carton
Fast Dissolving Liquid Gels!
MAXIMUM STRENGTH
NDC 63824-519-24
Mucinex®
FAST-MAX
®
DAY
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
HEADACHE
BODY PAIN
SORE THROAT
FEVER
CHEST CONGESTION
COUGH
ALL IN
ONE
*
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSURE
16
LIQUID GELS
(Liquid Filled
Capsules)
NIGHT
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl – Nasal Decongestant
HEADACHE
BODY PAIN
SORE THROAT
FEVER
ITCHY THROAT
COUGH
ALL IN
ONE
*
NASAL CONGESTION
SNEEZING
RUNNY NOSE
8
LIQUID GELS
(Liquid Filled
Capsules)
24 TOTAL
AGES 12+
INGREDIENTS AND APPEARANCE
| MAXIMUM STRENGTH MUCINEX FAST-MAX DAY COLD AND FLU AND NIGHT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride kit |
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| Labeler - RB Health (US) LLC (081049410) |