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| Product NDC Code | 81660-777 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nighttime cold and flu |
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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 | LIQUID | ||||||
| RxCUI drug identifier | 1043400 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Grimann, S.A. de C.V. | ||||||
| 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 30 mL) Purpose Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant Doxylamine succinate 12.5 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.take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL 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 alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose
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.Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Purpose
Information about the drug product’s indications for use.Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose and sneezing
Spl product data elements
Usually a list of ingredients in a drug product.Nighttime Cold and Flu Acetaminophen, Dextromethorphan, Doxylamine succinate WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCRALOSE PROPYLENE GLYCOL ALCOHOL D&C YELLOW NO. 10 GLYCERIN SORBITOL CITRIC ACID ACETATE FD&C BLUE NO. 1 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN Nighttime Cold and Flu Liquid Cherry Acetaminophen, Dextromethorphan, Doxylamine succinate WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCRALOSE ALCOHOL D&C YELLOW NO. 10 GLYCERIN SORBITOL CITRIC ACID ACETATE FD&C BLUE NO. 1 PROPYLENE GLYCOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN
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.p1 p2 p3 p4 p5
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.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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
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 every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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