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| Product NDC Code | 0363-4670 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime nighttime cold and cough |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1043400, 1113705, 2637726 |
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| Application Number | M012 | ||||
| Labeler Name | Walgreens | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 15 mL) Daytime Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Active ingredients for (in each 30 mL) Nighttime Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions DAYTIME do not take more than directed (see Overdose warning) do not take more than 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 adult and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use NIGHTTIME do not take more than directed (see Overdose warning) do not take more than 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 adult and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use
| adult and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients DAYTIME citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum NIGHTTIME acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10 FD&C green #3, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, trisodium citrate dihydrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses DAYTIME temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation NIGHTTIME temporarily relieves common cold/flu symptoms minor aches and pain headache sore throat runny nose and sneezing fever cough due to minor throat and bronchial irritations as may occur with a cold
Purpose
Information about the drug product’s indications for use.Purposes for Day Time Pain reliever/Fever reducer Cough suppressant Nasal decongestant
Purpose for Night Time Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Daytime Nighttime Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SORBITOL SUCRALOSE XANTHAN GUM Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ALCOHOL D&C YELLOW NO. 10 FD&C GREEN NO. 3 FD&C YELLOW NO. 6 PROPYLENE GLYCOL WATER TRISODIUM CITRATE DIHYDRATE HIGH FRUCTOSE CORN SYRUP POLYETHYLENE GLYCOL, UNSPECIFIED SACCHARIN SODIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Compare to the active ingredients in Vick® Dayquil® Cold & Flu & Vick® Nyquil® Cold & Flu†† DAYTIME • NON-DROWSY Cold & Cough ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT Multi-Symptom Relieves aches, fever,& sore throat, cough & nasal congestion For ages 6 years & over Alcohol free Antihistamine free FL OZ (mL) NIGHTTIME Cold & Flu ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr 30 mg / COUGH SUPPRESSANT DOXYLAMINE SUCCINATE 12.5 mg / ANTIHISTAMINE Multi-Symptom Relieves headache, fever, sore throat, minor aches & pains, sneezing, runny nose & cough For ages 12 years & over Nighttime relief ALCOHOL 10% FL OZ (mL) WHEN USING OTHER DAYTIME OR NIGHTTIME PRODUCTS, CAREFULLY READ EACH LABEL TO ENSURE CORRECT DOSING TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION †† These products are not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and Nyquil® are registered trademarks of the Procter & Gamble Company. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Product Label WALGREENS Daytime Non-Drowsy Cold & Flu, Nighttime Cold & Flu Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg, Acetaminophen 650 mg, Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if have DAYTIME liver disease high blood pressure heart disease thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease glaucoma cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if the child is DAYTIME if you are taking the blood thinning drug warfarin NIGHTTIME taking sedatives or tranquilizers taking the blood thinning drug warfarin
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use DAYTIME NIGHTTIME 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 contain an MAOI, ask a doctor or pharmacist before taking this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. 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) right away. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. NIGHTTIME pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product DAYTIME do not exceed recommended dosage. NIGHTTIME excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information DAYTIME each 15 mL contains: sodium 12 mg store between 20-25ºC (68º-77ºF). Do not refrigerate. NIGHTTIME each 30 mL contains: potassium 5 mg each 30 mL contains: sodium 19 mL store between 20-25ºC (68-77ºF). Do not refrigerate
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings DAYTIME NIGHTTIME Liver warning : This product contain acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day 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 DAYTIME NIGHTTIME 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 contain an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if have DAYTIME liver disease high blood pressure heart disease thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease glaucoma cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if the child is DAYTIME if you are taking the blood thinning drug warfarin NIGHTTIME taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product DAYTIME do not exceed recommended dosage. NIGHTTIME excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. NIGHTTIME pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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) right away. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API