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| Product NDC Code | 0363-6220 | ||||
|---|---|---|---|---|---|
| Drug Name | Wag hbp daytime and nighttime cold and flu |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M013 | ||||
| Labeler Name | WALGREENS CO. | ||||
| 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) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg Pain reliever/ fever reducer Cough suppressant Antihistamine
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Purpose Pain reliever/Fever reducer Cough suppressant
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 ▪ 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
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 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 Anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, Propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Inactive ingredients Anhydrous citric acid, disodium edetate, FD&C Yellow No. 6, flavor, glycerin, menthol, potassium citrate, propylene glycol, purified water, , sodium benzoate, 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.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
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Purpose
Information about the drug product’s indications for use.Pain reliever/ fever reducer Cough suppressant Antihistamine
Purpose Pain reliever/Fever reducer Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.WAG HBP Daytime and Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate Walgreen HBP Daytime COLD AND FLU MULTI-SYMPTOM RELIEF Acetaminophen, Dextromethorphan Hydrobromide ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM Walgreen HBP NIghttime COLD AND FLU NIGHTTIME RELIEF Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE
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.PRINCIPAL DISPLAY PANEL - Kit Carton VALUE PACK High Blood Pressure Daytime COLD & FLU Acetaminophen , Dextromethorphan HBr • Headache, Fever, Sore Throat • Minor Aches & Pains • Cough Daytime 8 FL OZ (236 ml) BOTTLE High Blood Pressure Nighttime COLD & FLU Nighttime Relief Acetaminophen , Doxylamine Succinate, Dextromethorphan HBr • Headache, Fever, Sore Throat • Minor Aches & Pains • Sneezing, Runny Nose • Cough Sugar Free & No Added Alcohol Nighttime 8 FL OZ (236 ml) BOTTLE TOTAL 16 FL OZ (472 ml) WAG HBP Daytime and Nightttime Cold and Flu Value Pack
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.HBP Nighttime Cold & Flu Drug Facts
Distributed by:
HBP Daytime Cold & Flu Relief 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.
Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-467-2748
Questions? 1-866-467-2748
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ▪ each 30 mL contains: sodium 16 mg ▪ store at room temperature
Other information • each 15 mL contains : sodium 46 mg • store at room temperature and do not refrigerate.
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 See carton for complete warnings If pregnant or breast-feeding, ask a health professional before use. 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.
Warnings See carton for complete warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away at1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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