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| Product NDC Code | 82673-191 | ||||
|---|---|---|---|---|---|
| Drug Name | Nighttime cold and cough |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1049906 | ||||
| Application Number | M012 | ||||
| Labeler Name | KinderFarms, LLC | ||||
| 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 5 mL) Diphenhydramine HCl 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 adults and children 6 years and over: do not exceed more than 6 doses in any 24-hours unless directed by a doctor measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product shake well before using mL= milliliter Age Dose adults and children 12 years of age and over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use
| Age | Dose |
| adults and children 12 years of age and over | 10 mL every 4 hours |
| children 6 to under 12 years of age | 5 mL every 4 hours |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Organic agave syrup, non-GMO citric acid, organic natural flavor, purified water
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: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies the impulse to cough cough to help you get to sleep cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant the intensity of coughing
Purpose
Information about the drug product’s indications for use.Purposes Antihistamine/ Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Nighttime Cold and Cough Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AGAVE TEQUILANA JUICE CITRIC ACID MONOHYDRATE WATER
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 KIDS ' Ages 6 yrs+. NIGHTTIME COLD & COUGH Diphenhydramine HCl 12.5 mg per 5 mL Antihistamine/Cough Suppressant Organic Cherry Flavor DOSING CUP INCLUDED FL OZ (mL) TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING DISTRIBUTED BY: KinderFarms® Redondo Beach, CA 90277 USA
Package Label KINDERMED Kids Nighttime Cold & Cough Diphenhydramine HCl 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 the chld has glaucoma cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema diabetes a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland
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 taking sedatives or tranquilizers
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 in a child under 4 years of age with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy
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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? Call 424-235-0355
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 do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breat-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20-25º (68-77ºF). Do not refrigerate protect from light
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 Do not use in a child under 4 years of age with any other product containing diphenhydramine, even one used on skin for the purpose of making your child sleepy Ask a doctor before use if the chld has glaucoma cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema diabetes a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breat-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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