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| Product NDC Code | 11673-984 | ||||
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| Drug Name | Cold and flu daytime-nighttime |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1297288, 1656815, 2634364 |
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| Application Number | part341 | ||||
| Labeler Name | TARGET CORP | ||||
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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 325MG D0EXTROMETHORHAN HBR10 MG, GUAIFENESIN 200 MG , PHENYLEPHRINE HCL 5 MG
3 (in each softgel) Acetaminophen 325mg Dextromethorphan HBR 10 mg Doxylamine Succinate 6.25 mg PhenylephrineHCl,
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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 Softgels per 24 hrs - adults & children 12 yrs & over 2 Softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions take only as directed - do not exceed 8 softgels per 24 hours - adults & children 12 yrs & over 2 softgels with water every 6 hrs - children 4 to under 12 yrs ask a doctor - children under 4 yrs 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,FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide
FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
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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 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 Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant MINOR ACHES AND PAINS, FEVER NASAL CONGESTION AND SINUS PRESSURE SNEEZING, RUNNY NOSE COUGH
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Purpose
Information about the drug product’s indications for use.PAIN RELIEVER-FEVER REDUCER COUGH SUPPRESENT MINOR ACHES AND PAINS CHEST CONGESTION
MINOR ACHES AND PAINS, FEVER NASAL CONGESTION AND SINUS PRESSURE SNEEZING, RUNNY NOSE COUGH
Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough
Spl product data elements
Usually a list of ingredients in a drug product.COLD AND FLU DAYTIME-NIGHTTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL COLD AND FLU DAYTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN GLYCERIN ACETAMINOPHEN ACETAMINOPHEN GELATIN SHELLAC SORBITOL POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 WATER POVIDONE 73 COLD AND FLU NIGHTTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL GELATIN SHELLAC POVIDONE TITANIUM DIOXIDE FD&C BLUE NO. 1 PROPYLENE GLYCOL DOXYLAMINE SUCCINATE DOXYLAMINE WATER POLYETHYLENE GLYCOL, UNSPECIFIED GLYCERIN SORBITOL ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 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.COMBO SEVERE
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.COLD AND FLU DAYTIME SEVERE SOFTGELS (625T) DRUG FACTS
COLD AND FLU NIGHTIME SEVERE SOFTGELS (626T) DRUG FACTS
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.
Keep out of reach of children. Overdose warning 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
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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 8sogtgels This product contains acetaminophen. Severe liver damage may occur if you take more than 8 LiquiCaps 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.
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 ... 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.
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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