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| Product NDC Code | 24689-152 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime nighttime cold flu relief |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1086997, 1094549, 2634564 |
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| Application Number | M012 | ||||
| Labeler Name | APNAR PHARMA LP | ||||
| Packages |
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Overdosage of DAYTIME NIGHTTIME COLD FLU RELIEF
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning: Taking more than the recommended dose can 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 adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients for Daytime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Active ingredients for Nighttime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 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 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over: take 2 softgels with water every 4 hours. children under 12 years: do not use Nighttime do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Daytime Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
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 cough due to minor throat and bronchial irritation nasal congestion headache minor aches and pains Fever sore throat Uses Nighttime temporarily relieves common cold and flu symptoms cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing
Purpose
Information about the drug product’s indications for use.Purposes for Daytime Pain reliever/fever reducer Cough suppressant Nasal decongestant
Purposes for Nighttime Pain reliever/fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.DAYTIME NIGHTTIME COLD FLU RELIEF Acetaminophen, Dextromethorphan hbr, Doxylamine succinate, Phenylephrine hcl Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan hbr, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN SORBITAN POVIDONE FD&C BLUE NO. 1 SORBITOL DOXYLAMINE SUCCINATE DOXYLAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PROPYLENE GLYCOL WATER POLYETHYLENE GLYCOL, UNSPECIFIED D&C YELLOW NO. 10 GLYCERIN GELATIN AA7 Daytime Cold Flu Relief Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 SORBITOL PROPYLENE GLYCOL SORBITAN GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 GLYCERIN POVIDONE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN AA6
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.†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps® Daytime NDC 24689-152-01 Multi-Symptom Cold & Flu Relief Acetaminophen 325 mg- Pain reliever / Fever reducer Dextromethorphan HBr 10 mg - Cough suppressant Phenylephrine HCI 5 mg - Nasal decongestant Relieves: Aches, fever, sore throat Cough Nasal congestion Non-drowsy Alcohol-Free Antihistamine-Free Softgels** (** Liquid-filled capsules) Nighttime Multi-Symptom Cold & Flu Relief Acetaminophen 325 mg - Pain reliever / Fever reducer Dextromethorphan HBr 15 mg - Cough suppressant Doxylamine succinate 6.25 mg - Antihistamine Relieves: Aches, fever, sore throat Cough Runny nose, sneezing Softgels** Alcohol-free (**Liquid-filled capsules) When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing. †This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Distributed by: APNAR PHARMA LP CHINO, CA, USA, 91710 Rev.: 04/2023 Daytime and Nighttime Soft Gel-Carton-label
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.
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 1-855-642-2594
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 15-30°C (59-86°F) avoid excessive heat
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 Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this 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. Nighttime Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this 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 Daytime 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 this product. 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 contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have Daytime liver disease heart disease diabetes thyroid disease high blood pressure cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema Nighttime liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are Daytime taking the blood thinning drug warfarin Nighttime taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product Daytime do not exceed recommended dosage Nighttime do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if Daytime nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion 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. Nighttime pain 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 headache that lasts. These could be a signs of a serious condition If pregnant or breast-feeding, ask a health professional before use
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