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NDC 00363-6489-01 Severe Congestion and Cough, Cold and Flu Details
Severe Congestion and Cough, Cold and Flu
Severe Congestion and Cough, Cold and Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-6489-01Last Updated: 11/30/2022
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: 00363-6489-01Last Updated: 11/30/2022
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: 00363-6489-01Last Updated: 11/30/2022
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: 00363-6489-01Last Updated: 11/30/2022
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: 00363-6489-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-6489 |
|---|---|
| Product ID | 0363-6489_f9f5cdc9-9fe1-4875-b18b-0388bf86af7c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Severe Congestion and Cough, Cold and Flu |
| Proprietary Name Suffix | Daytime, Nighttime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl |
| 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 | Walgreen Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 00363-6489-01 (00363648901)
| NDC Package Code | 0363-6489-01 |
|---|---|
| Billing NDC | 00363648901 |
| Package | 1 KIT in 1 PACKAGE (0363-6489-01) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a9eca15f-46db-489e-b2b3-c583785cb1e4 Details
Active ingredients (in each caplet) (Daytime Severe Congestion & Cough)
Active ingredients (in each caplet) (Nighttime Cold & Flu)
Uses (Daytime only)
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- nasal congestion due to a cold
- the intensity of coughing
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Uses (Nighttime only)
Warnings (Nighttime only)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
- if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
Ask a doctor before use if you have
- heart disease
- diabetes
- thyroid disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis Nighttime only)
- glaucoma (Nighttime only)
- liver disease (Nighttime only)
Ask a doctor or pharmacist before use if you are (Nighttime only)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizer
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- marked drowsiness may occur (Nighttime only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever (Daytime only)
- redness or swelling is present (Nighttime only)
- pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
- new symptoms occur (Nighttime only)
- fever gets worse or lasts more than 3 days (Nighttime only)
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.
Directions
Other information
Inactive ingredients (Daytime only)
Inactive ingredients (Nighttime only)
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide
Principal display panel
Walgreens
NDC 0363-6489-01
Compare to Maximum Strength Mucinex® Fast-Max®
Day Time Severe Congestion & Cough & Night Time
Cold & Flu active ingredients††
|
DAYTIME
Severe DEXTROMETHORPHAN HBr / MAXIMUM STRENGTH MULTI-SYMPTOM • Controls cough • Relieves nasal & chest congestion • Thins & loosens mucus
20
ACTUAL SIZE |
NIGHTTIME
Cold & ACETAMINOPHEN / MAXIMUM STRENGTH MULTI-SYMPTOM • Relieves aches, fever,
10
ACTUAL SIZE |
30 TOTAL CAPLETS
50844 REV0517A64869401
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD. DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® Fast-Max® Day Time Severe Congestion & Cough & Night Time Cold & Flu.
Walgreens 44-648694
INGREDIENTS AND APPEARANCE
| SEVERE CONGESTION AND COUGH, COLD AND FLU
DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit |
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| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(0363-6489) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | pack(0363-6489) | |