NDC 67091-376 Childrens Pain Relief Oral Suspension Dye Free

Acetaminophen

NDC Product Code 67091-376

NDC 67091-376-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Childrens Pain Relief Oral Suspension Dye Free with NDC 67091-376 is a a human over the counter drug product labeled by Winco Foods, Llc. The generic name of Childrens Pain Relief Oral Suspension Dye Free is acetaminophen. The product's dosage form is suspension and is administered via oral form.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Childrens Pain Relief Oral Suspension Dye Free Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Winco Foods, Llc
Labeler Code: 67091
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-18-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Childrens Pain Relief Oral Suspension Dye Free Product Label Images

Childrens Pain Relief Oral Suspension Dye Free Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

DRUG FACTS

Otc - Active Ingredient

Active ingredient (In each 5 mL = 1 teaspoonful)Acetaminophen 160 mg

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat■ toothache

Warnings

WarningsLiver warningThis product contains acetaminophen. Severe liverdamage may occur if your child takes: ■ more than 5doses in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophenAllergy alertAcetaminophen may cause severe skin reactions.Symptoms may include: ■ skin reddening ■ blisters■ rash. If skin reaction occurs, stop use and seekmedical help right awaySore throat warningIf sore throat is severe, persists for more than 2 days, isaccompanied or followed by fever, headache, rash,nausea or vomiting, consult a doctor promptly.

Otc - Do Not Use

Do not use■ with any other drug containing acetaminophen(prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctoror pharmacist.■ if your child is allergic to acetaminophen or any ofthe inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if your child has liver diseaseAsk a doctor or pharmacist before use If your child is taking the blood thinning drug warfarin.

Otc - When Using

When using this product do not exceed recommended dose (see overdose warning)

Otc - Stop Use

Stop use and ask a doctor if■ pain gets worse or lasts more than 5 days ■ fevergets worse or lasts more than 3 days ■ newsymptoms occur ■ redness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warningTaking more than the recommended dose (overdose)may cause liver damage. In case of overdose, getmedical help or contact a Poison Control Center rightAway. (1-800-222-1222) Quick medical attentionis critical for adults as well as for children even if youdo not notice any signs or symptoms.

Dosage & Administration

Directions■ this product does not contain directions or complete warnings for adult use.■ shake well before using■ mL = milliliter; tsp = teaspoonful■ find right dose on chart below. If possible, use   weight to dose; otherwise, use age.■ if needed, repeat dose every 4 hours while symptoms last■ do not give more than 5 times in 24 hours■ do not give for more than 5 days unless directed by a doctorWeight (lb)Age (yr)Dose (mL or tsp)*under 24under 2 yearsask a doctor24-352-3 years 5 mL (1 tsp)36-474-5 years7.5 mL (1 1/2 tsp)48-596-8 years10 mL (2 tsp)60-719-10 years12.5 mL (2 1/2 tsp)72-9511 years15 mL (3 tsp)* or use as directed by a doctorAttention: use only enclosed dosing cup specificallydesigned for use with this product. Do not use anyother dosing device.

Other Safety Information

Other information■ each 5 mL (1 tsp) contains: sodium 3 mg■ store between 20-25ºC (68-77ºF)■do not refrigerate■ Keep carton for full directions for use.

Inactive Ingredient

Inactive ingredients anhydrous citric acid,butylparaben, flavor, glycerin, high fructose cornsyrup, microcrystalline cellulose andcarboxymethylcellulose sodium, propylene glycol,purified water, sodium benzoate, sorbitol solution,sucralose, xanthan gum

Otc - Questions

Questions? Call 1-800-824-1706 Monday - Friday 9am - 4pm MST

Package Labeling

WinCo®FOODSORAL SUSPENSIONPain ReliefChildren's**Compare to the active ingredient inChildren's TYLENOL​® Oral SuspensionACETAMINOPHEN160  mg per 5 mL/PAIN RELIEVER - FEVER REDUCERAlcohol FreeAspirin & Ibuprofen FreeFor Ages 2 - 11 YearsDyeFreeCherryFlavor4 FL OZ (118 mL) 160 mg per 5 mLDISTRIBUTED BY: WINCO FOODS,LLC, BOISE, ID 83704**This product is not manufactured or distributed byMcNEIL CONSUMER HEALTHCARE, distributor ofChildren's TYLENOL​® Oral Suspension.DO NOT USE IF PRINTED SEALUNDER CAP IS TORN OR MISSINGCarton LabelBottle Labelres

* Please review the disclaimer below.