NDC 45014-137 Childrens Accudial Pain Reliever/ Fever Reducer

NDC Product Code 45014-137

NDC 45014-137-04

Package Description: 118 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Childrens Accudial Pain Reliever/ Fever Reducer with NDC 45014-137 is a product labeled by Accudial Pharmaceutical, Inc.. The generic name of Childrens Accudial Pain Reliever/ Fever Reducer is . The product's dosage form is and is administered via form.

Labeler Name: Accudial Pharmaceutical, Inc.

Dosage Form: -

Product Type: 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.

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SORBITOL (UNII: 506T60A25R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

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

Labeler Name: Accudial Pharmaceutical, Inc.
Labeler Code: 45014
Start Marketing Date: 04-25-2012 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: 12-31-2017 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: I 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

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Childrens Accudial Pain Reliever/ Fever Reducer Product Label Images

Childrens Accudial Pain Reliever/ Fever Reducer 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

DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.Palm Beach Gardens, FL 33408

Active Ingredient (In Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:the common coldfluheadachesore throattoothacheTemporarily reduces fever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if your child takes:more than 5 doses in 24 hours, which is the maximum daily amount.with other drugs containing acetaminophen.

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.

Otc - Do Not Use

  • Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacistIf your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease.Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

Otc - Ask Doctor/Pharmacist

Ask 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 use more than directed.

Otc - Stop Use

  • Stop use and ask a doctor if:Pain gets worse or lasts more than 5 days.Fever gets worse or lasts more than 3 days.New symptoms occur.Redness or swelling is present.These could be signs of a serious condition.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult use.shake well before usingif needed, repeat dose every 4 hoursdo not use more than 5 times in 24 hourswhen weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.when weight is unknown: use the age chart on the rotating label.use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing deviceAge (yr)Dose (mL or tsp)tsp. = teaspoonmL = milliliterunder 6 mos.ask a doctor6 mos. to under 22.5 mL or ½ tsp.2 to under 45 mL or 1 tsp.4 to under 67.5 mL or 1½ tsp.6 to under 910 mL or 2 tsp.9 to under 1112.5 mL or 2½ tsp.11 to under 1215 mL or 3 tsp.or as directed by a doctorAsk a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

Other Information

  • Each teaspoon contains: sodium 2 mgstore between 20°-25°C (68°-77°F)tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients

Artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

877-434-2036

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