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NDC 11822-0717-00 day severe cold night cold and flu Details
day severe cold night cold and flu
day severe cold night cold and flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. 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: 11822-0717-00Last 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: 11822-0717-00Last Updated: 11/30/2022
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: 11822-0717-00Last Updated: 11/30/2022
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: 11822-0717-00Last 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: 11822-0717-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 11822-0717 |
|---|---|
| Product ID | 11822-0717_54f3d47d-22f7-4622-a272-f4a270a7cb73 |
| 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 | day severe cold night cold and flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, doxylamine succinate |
| 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 | Rite Aid Corporation |
| 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 11822-0717-00 (11822071700)
| NDC Package Code | 11822-0717-0 |
|---|---|
| Billing NDC | 11822071700 |
| Package | 1 KIT in 1 KIT (11822-0717-0) |
| Marketing Start Date | 2017-06-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aa930ec9-3d37-4ef2-8488-63967370bf79 Details
Active ingredients (in each liquid gel) – DAY Severe Cold
Purposes – DAY Severe Cold
Active ingredients (in each liquid gel) – NIGHT Cold & Flu
Purposes – NIGHT Cold & Flu
Uses
- •
- temporarily relieves these common cold and flu symptoms:
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- cough
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- minor aches and pains
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- headache
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- nasal congestion
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- sore throat
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- runny nose and sneezing (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 (NIGHT only)
- •
- temporarily reduces fever
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using these products
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 these products.
- •
- if you have ever had an allergic reaction to these products or any of their ingredients
Ask a doctor before use if you have
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- liver disease
- •
- heart disease
- •
- diabetes
- •
- high blood pressure
- •
- thyroid disease
- •
- trouble urinating due to an enlarged prostate gland
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- glaucoma (NIGHT only)
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- 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
When using these products
- •
- 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 rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Directions
Inactive ingredients (DAY only)
Inactive ingredients (NIGHT only)
Package/Label Principal Display Panel
COMBO PACK
Compare to the active ingredients of Mucinex® Fast-Max® Day Severe Cold & Mucinex® Fast-Max® Night Cold & Flu
fast dissolving liquid gels
MAXIMUM STRENGTH
daytime
day
severe cold
acetaminophen
dextromethorphan HBr
guaifenesin
phenylephrine HCl
pain reliever/fever reducer
cough suppressant
expectorant
nasal decongestant
relieves aches, fever & sore throat
controls cough
relieves nasal & chest congestion
thins & loosens mucus
ACTUAL SIZE
16 LIQUID GELS
(liquid filled capsules)
24 TOTAL for ages 12+
MAXIMUM STRENGTH
nighttime
night
cold & flu
acetaminophen
dextromethorphan HBr
doxylamine succinate
phenylephrine
pain reliever/fever reducer
cough suppressant
antihistamine
nasal decongestant
relieves aches, fever & sore throat
controls cough
relieves nasal congestion
relieves runny nose & sneezing
ACTUAL SIZE
24 TOTAL
for ages 12+
8 LIQUID GELS
(liquid filled capsules)
INGREDIENTS AND APPEARANCE
| DAY SEVERE COLD NIGHT COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit |
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| Labeler - Rite Aid Corporation (014578892) |