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| Product NDC Code | 0067-0112 | ||||
|---|---|---|---|---|---|
| Drug Name | Theraflu severe cold relief nighttime soft chews |
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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 | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 2691689 | ||||
| Application Number | M012 | ||||
| Labeler Name | Haleon US Holdings 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 chewable tablet) Acetaminophen 325 mg 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 do not use more than directed do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 hours children under 12 years of age do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients brown iron oxide, calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk
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 these symptoms due to a cold: minor aches and pains sore throat pain headache runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/Fever reducer Antihistamine/Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Theraflu Severe Cold Relief Nighttime Soft Chews Acetaminophen, Diphenhydramine HCl BROWN IRON OXIDE CALCIUM GLUCONATE MONOHYDRATE CARBOXYMETHYLCELLULOSE CALCIUM CARNAUBA WAX CORN SYRUP CROSPOVIDONE, UNSPECIFIED FD&C RED NO. 40 GLYCERIN MANNITOL STARCH, CORN SODIUM GLUCONATE SORBITOL SORBITOL SOLUTION SUCRALOSE SUCROSE COW MILK ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE N
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.Package/Label Principal Display Panel NEW THERAFLU SEVERE COLD RELIEF NIGHTTIME Soft CHEWS Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant FAST relief ANYWHERE fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes 20 CHEWABLE TABLETS Chew tablets completely before swallowing Apple Cinnamon Flavor Theraflu SC Night Soft Chews 20 ct
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.Other information each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium, 7 mg store at a controlled room temperature 20-25°C (68-77°F)
Generic Section Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
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 you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma 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 you are 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 in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin
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 right away. Prompt medical attention is critical for adults 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 1-855-328-5259
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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough gets worse or lasts more than 7 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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 in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough gets worse or lasts more than 7 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults 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