FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
- more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Allery 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.
- 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- cough comes back or occurs, with rash or headache that lasts.
These could be signs of a serious condition.
ask a health professional before use.
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 (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a sodium-restricted diet
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
taking the blood thinning drug warfarin.
Stop use and ask a doctor if- redness or swelling is present
- new symptoms occur
- nervousness, dizziness or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- cough comes back or occurs, with rash or headache that lasts.
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Daytime Cold And Flu Manufacturers
- Best Choice (Valu Merchandisers Company)
Daytime Cold And Flu | Best Choice (valu Merchandisers Company)
do not take more than directed (see overdose warning) do not exceed 5 doses (children) or 6 doses (adults) per 24 hours use dosage cup provided tbsp=tablespoon, mL=milliliter age dose adults and children 12 years and over 30 mL every 4 hours children 6 to 11 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing - Shopko Stores Operating Co., Llc
- Meijer Distribution Inc
- Meijer Distribution Inc
Daytime Cold And Flu | Fred's, Inc.
take only as directed – see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over
30 mL (2 TBSP) every 6 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing - Meijer Distribution Inc
Daytime Cold And Flu | Meijer Distribution Inc
• take only as directed – see Liver warning • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
2 softgels with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing - Humanwell Puracap Pharmaceutical (Wuhan), Ltd.
Daytime Cold And Flu | Humanwell Puracap Pharmaceutical (wuhan), Ltd.
take only as directed - see Overdose warning do not exceed 4 doses per 24 hoursAdults and children 12 years of age and older
Swallow 2 softgels with water every 4 hoursChildren 4 to under 12 years of age
ask a doctorchildren under 4 years of age
do not useIf taking NIGHTTIME and DAYTIME products, carefully read each label to insure correct dosing.
- Meijer Distribution Inc
Daytime Cold And Flu | Meijer Distribution Inc
• take only as directed – see Liver warning • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
2 softgels with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing - Velocity Pharma
- Humanwell Puracap Pharmaceutical (Wuhan), Ltd.
Daytime Cold And Flu | Humanwell Puracap Pharmaceutical (wuhan), Ltd.
take only as directed - see Overdose warning do not exceed 4 doses per 24 hoursadults and children 12 years of age and older
take 2 softgels with water every 4 hourschildren 4 to under 12 years of age
ask a doctorchildren under 4 years of age
do not useWhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
- Kroger Company
Daytime Cold And Flu | Direct Rx
Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.
The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.
Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.
The initial dosage of prednisone may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)
Alternate Day Therapy
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1 1/4 to 1 1/2 days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.
2. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).
6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.
9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
- Aafes/your Military Exchanges
- P & L Development, Llc
Daytime Cold And Flu | P & L Development, Llc
do not take more than directed (see overdose warning) do not exceed 4 doses in any 24 hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL=milliliter age dose adults and children 12 years and over 30 mL every 4 hours children 6 to 11 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing
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