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| Product NDC Code | 30142-086 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Kroger nighttime cold and flu softgel |
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| Type | Brand | ||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 1094549 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | The Kroger Company | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Kroger Nighttime Cold and Flu Softgel
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning: Taking more than directed can cause serious health problems. 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 & 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 (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: • take only as directed - see Overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 Softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
| adults & children 12 yrs & over | 2 Softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution
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: temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever / Fever reducer Cough suppressant Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Kroger Nighttime Cold and Flu Softgel Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN 808
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.Packaging Kroger -086
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
COMPARE TO the active ingredients of VICKS ® NYQUIL ® COLD & FLU NIGHTTIME RELIEF LIQUICAPS ® *See bottom panel POWERFUL NIGHTTIME RELIEF OUR PHARMACIST RECOMMENDED Multi-Symptom Relief TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN OR SHOWS ANY SIGN OF TAMPERING READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 MADE IN UAE For More Product Information , Scan UPC Using Your Kroger App or Call 800-632-6900 *This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks ® , NyQuil ® , and LiquiCaps ® are registered trademarks of The Proctor & Gamble Company. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Our Brands, Our Guarantee. Love It or Your Money Back. www.kroger.com
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: 1-800-632-6900
Storage and handling
Information about safe storage and handling of the drug product.Other information: • store at room temperature between 20-25 °C (68-77 °F)
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: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses in 24 hrs, which is the maximum daily amount for this product • 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, see 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 this product. • to make a child sleep Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema • trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed. • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, & tranquilizers may increase drowsiness Stop use and ask a doctor if • 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 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 directed can cause serious health problems. 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 & 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