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NDC 69842-0477-03 Daytime Nighttime Cold and Flu Details
Daytime Nighttime Cold and Flu
Daytime Nighttime Cold and Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY. 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: 69842-0477-03Last 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: 69842-0477-03Last 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: 69842-0477-03Last 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: 69842-0477-03Last 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: 69842-0477-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 69842-0477 |
|---|---|
| Product ID | 69842-477_ee2a7cb7-f135-1325-e053-2995a90aa892 |
| 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 | Daytime Nighttime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, 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 | CVS PHARMACY |
| 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 69842-0477-03 (69842047703)
| NDC Package Code | 69842-477-03 |
|---|---|
| Billing NDC | 69842047703 |
| Package | 1 KIT in 1 CARTON (69842-477-03) * 10 TABLET, COATED in 1 BLISTER PACK * 10 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2020-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a2f55b81-c9ab-2f78-e053-2a95a90a889e Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough (DAY TIME SEVERE COLD ONLY)
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (NIGHT TIME COLD & FLU ONLY)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME SEVERE COLD ONLY)
- temporarily reduces fever
Warnings
Liver warning
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 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.
- with any other product containing diphenhydramine, even one used on skin (NIGHT TIME COLD & FLU 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME COLD & FLU ONLY)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME COLD & FLU ONLY)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME SEVERE COLD ONLY)
- cough that occurs with too much phlegm (mucus) (DAY TIME SEVERE COLD ONLY)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NIGHT TIME COLD & FLU ONLY)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT TIME COLD & FLU ONLY)
- marked drowsiness may occur (NIGHT TIME COLD & FLU ONLY)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME COLD & FLU ONLY)
- avoid alcoholic drinks (NIGHT TIME COLD & FLU ONLY)
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME COLD & FLU 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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take Day Time and Night Time caplets at the same time
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients
DAY TIME SEVERE COLD
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
CVS Health®
NDC 69842-477-03
MAXIMUM STRENGTH®
Daytime Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough suppressant
Guaifenesin
Expectorant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Headache + Body Pain
Fever + Sore Throat
Cough + Chest Congestion
Nasal Congestion
FOR AGES 12+
Actual Size
20 DAYTIME CAPLETS
MAXIMUM STRENGTH*
Nighttime Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Headache + Body Pain
Fever + Sore Throat
Nasal Congestion
Sneezing & Runny Nose
FOR AGES 12+
Actual Size
10 NIGHTTIME CAPLETS
TOTAL 30 CAPLETS
INGREDIENTS AND APPEARANCE
| DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit |
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| Labeler - CVS PHARMACY (062312574) |