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| Product NDC Code | 11673-969 | ||||
|---|---|---|---|---|---|
| Drug Name | Daytime- nighttime cold and flu |
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| Type | Brand | ||||
| Route | ORAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 1086997, 1094549, 2634564 |
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| 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 softgels) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 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 take only as directed do not exceed 4 doses 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
DIRECTION take only as directed do not exceed 4 doses 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
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| 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 |
| DIRECTION |
|
| 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C blue 1, FD&C Yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide
FD&C red #40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, 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.Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Purpose
Information about the drug product’s indications for use.PURPOSE Pain reliever/fever reducer Cough suppressant Nasal decongestant
temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
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Spl product data elements
Usually a list of ingredients in a drug product.DAYTIME- NIGHTTIME COLD AND FLU DAYTIME NIGHTTIME COLD AND FLU DAYTIME COLD AND FLU MULTI SYMPTOM DAYTIME COLD AND FLU MULTI SYMPTOM FD&C RED NO. 40 GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER SHELLAC POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL TITANIUM DIOXIDE SORBITOL POVIDONE GELATIN FD&C YELLOW NO. 6 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 70 NIGHTIME COLD AND FLU NIGHTIME COLD AND FLU SHELLAC DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE GLYCERIN PROPYLENE GLYCOL WATER SORBITOL POVIDONE ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 D&C YELLOW NO. 10 POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE GELATIN 71
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.48 ct
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.DAYTIME COLD AND FLU RELIEFDRUG FACTS DRUG FACTS
NIGHTIME DRUG FACTS 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. 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 & for children even if you do not notice any signs or symptoms.
Keep out of reach of children In case of overdose, get medical help or cotact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults and 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 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.
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 ... 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