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| Product NDC Code | 55629-012 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride |
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| Type | Generic | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 1086997 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | ONE2ZEE LIMITED LIABILITY COMPANY | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
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 serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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 (in each capsule) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 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 take only as recommended - see OVERDOSE warning do not exceed 6 doses per 24 hours Adults and children 12 years of age and older 2 LiquiCaps with water every 4 hours Children under 12 years of age ask doctor W hen using other DayQuil or NyQuil products, carefully read each label to insure correct dosing
| Adults and children 12 years of age and older | 2 LiquiCaps with water every 4 hours |
| Children under 12 years of age | ask doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, 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 common cold/flu symptoms: cough due to minor throat & bronchial irritation nasal congestion sore throat headache minor aches/pains fever
Purpose
Information about the drug product’s indications for use.Purose Pain reliever/ fever reducer Cough suppressant Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE K30 FD&C RED NO. 40 FD&C YELLOW NO. 6 TITANIUM DIOXIDE GELATIN GLYCERIN SORBITOL WATER IS1
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 - Shipping Label Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules Each Softgel Contains: (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Phenylephrine Hydrochloride USP 5mg) LOT NO: DRUM NO: MFG DATE: QUANTITY: NDC NO: 55629-012- EXP DATE: WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. Shipper Label
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 heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema
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 with other medicines containing acetaminophen 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.
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.
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 you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) 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.
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 use more than directed.
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 store at room temperature 59°-86°F (15°-30°C)
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.Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do Not Use with other medicines containing acetaminophen 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 heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) 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 the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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