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| Product NDC Code | 11673-979 | ||||||||
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| Drug Name | Maximum strength nighttime cold and flu |
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| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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], 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 | 1297288 | ||||||||
| Application Number | part341 | ||||||||
| Labeler Name | TARGET CORP | ||||||||
| 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.Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 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 -Do not take more than directed (see Overdose warning) do not exceed more than 8 softgels in any 24 hr- period - adults & children 12 yrs & older: take 2 Softgels every 4 hrs children under 12 yrs of age - Do not use.
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.FD&C Blue No. 1, gelatin, glycerin,polyethylene glycol , povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution titanium dioxide,
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.temporarily relieves common cold/flu symptoms: nasal congestion, cough, nasal congestion, minor aches and pains, sore throat, headache, runny nose and sneezing temporarily reduces fever controls cough to help you get to sleet
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.MAXIMUM STRENGTH NIGHTTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GELATIN POVIDONE PROPYLENE GLYCOL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL GLYCERIN SHELLAC TITANIUM DIOXIDE CAPSULE SHAPED 72
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.8 ct
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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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.Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 Softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy Alert : acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash Sore troat 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.
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