Childrens Multi-symptom Cold And Fever Relief
NDC Package 67091-221-18
Package Information
Childrens Multi-symptom Cold And Fever Relief is this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning)shake well before usedo not take more than 5 doses in any 24 hour periodif needed, repeat dose every 4 hours while symptoms lastdo not give more than 5 days unless directed by a doctormeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorChildren 6 to under 12 years of age: 10 mL in dosing cup provided Children under 6 years of age: do not use. Marketed by Winco Foods, Llc, this product is identified by NDC 67091-221 and is authorized under FDA application part341.
Identification & Billing
- RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension
- RxCUI: 1593450 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
- RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension
- RxCUI: 1593450 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension
- RxCUI: 1593450 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 67091 - Winco Foods, Llc
- 67091-221 - Childrens Multi-symptom Cold And Fever Relief
- 67091-221-18 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 67091-221 - Childrens Multi-symptom Cold And Fever Relief
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 67091-221-18 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Multi-symptom Cold And Fever Relief, labeled by Winco Foods, Llc. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Winco Foods, Llc on December 12, 2014. The current certification is valid through December 31, 2021.
How is this Winco Foods, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091022118. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.