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| Product NDC Code | 11673-972 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cold and flu daytime severe |
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| Type | Brand | ||||||||
| 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 | 1656815 | ||||||||
| 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.Active ingredients(in each softgel) Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
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 directed - do not exceed 8 LiquiCaps per 24 hrs - adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs - children 4 to under 12 yrs ask a doctor ... take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgelswith water every 4 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 polyethylene glycol 400, propylene glycol,povidone, shellac, titanium dioxide, gelatin, glycerin, soritol sorbitan solution, FD&C Blue no. 01, FD&C Red No. 40, Prified 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: nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - minor aches & pains - headache - fever - sore throat - reduces ... temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.PURPOSE: Minor aches and Pains, fever Nasal Congestion & Sinus Pressure Cough Chest Congestion
Spl product data elements
Usually a list of ingredients in a drug product.COLD AND FLU DAYTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL GUAIFENESIN GUAIFENESIN GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED WATER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL SORBITOL FD&C BLUE NO. 1 POVIDONE SHELLAC TITANIUM DIOXIDE GELATIN 73
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.24 count
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 In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222 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.Warnings Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product - with other ... Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels 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 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.
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