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| Product NDC Code | 55758-313 | ||||||||
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| Drug Name | Antigrip nighttime |
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| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 | POWDER, FOR SOLUTION | ||||||||
| RxCUI drug identifier | 1534666 | ||||||||
| Application Number | part341 | ||||||||
| Labeler Name | Pharmadel 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 & Purposes Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine
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| Dextromethorphan HBr 20 mg…………………………………………………………… | Cough suppressant |
| Phenylephrine HCI 10 mg…….………………………………..…………………………… | Nasal decongestant |
| Chlorpheniramine maleate 4 mg………………………………………………………… | Antihistamine |
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 EXCEED RECOMMENDED DOSE take every 4 hours; do not exceed 6 packets in a 24 hour period dissolve the contents of one packet into 8 oz. glass of hot water and sip while hot; consume entire drink within 10-15 minutes if using a microwave; add contents of one packet to 8 oz. glass of cool water, stir briskly before and after heating. Do not overheat. Age Dose adults and children 12 years of age and over one packet every 4 hours children under 12 years of age do not use
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| adults and children 12 years of age and over | one packet every 4 hours |
| children under 12 years of age | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, aspartame, citric acid, flavor, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, 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 Temporary relieves common cold/flu symptoms: sore throat headache muscular aches backaches minor aches and pains runny nose sneezing itching of the nose or throat stuffy nose itchy, watery eyes due to hay fever or other upper respiratory allergies nasal & sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Active ingredients (in each packet) Purposes Acetaminophen 650 mg……………………………………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 20 mg…………………………………………………………… Cough suppressant Phenylephrine HCI 10 mg…….………………………………..…………………………… Nasal decongestant Chlorpheniramine maleate 4 mg………………………………………………………… Antihistamine
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| | |
| Dextromethorphan HBr 20 mg…………………………………………………………… | Cough suppressant |
| Phenylephrine HCI 10 mg…….………………………………..…………………………… | Nasal decongestant |
| Chlorpheniramine maleate 4 mg………………………………………………………… | Antihistamine |
Spl product data elements
Usually a list of ingredients in a drug product.ANTIGRIP Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCI CITRIC ACID MONOHYDRATE SILICON DIOXIDE ISOPROPYL ALCOHOL MALTODEXTRIN WATER CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACESULFAME POTASSIUM ACESULFAME ASPARTAME SODIUM CITRATE SUCROSE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIBASIC CALCIUM PHOSPHATE
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 NDC 55758-313-18 ANTIGRIP® Nighttime Cold & Cough Box
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.Drugs Facts
Other information each packet contains: sodium 26.73 mg, potassium 9.71 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) avoid excessive heat and moisture TAMPER EVIDENT: Do not use if carton or packets are torn or punctured.
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 heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland taking sedatives or tranquilizers a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus)
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 the blood thinning drug warfarin 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 with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 7 days for pain or 3 days for fever unless directed by a doctor if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product to sedate a child
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 an accidental 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 & comments? 1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
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 doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present nervousness, dizziness, or sleeplessness occurs a persistent cough or symptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. 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 may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution 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 6 packets in 24 hours, which is the maximum daily amount for this product 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 with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 7 days for pain or 3 days for fever unless directed by a doctor if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product to sedate a child Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland taking sedatives or tranquilizers a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough is accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product may cause drowsiness; alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present nervousness, dizziness, or sleeplessness occurs a persistent cough or symptoms persists for more than 7 days, gets worse, tends to recur, or is accompanied by a fever, rash or persistent headache. 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 an accidental 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