NDC 0121-1781 Childrens Acetaminophen

NDC Product Code 0121-1781

NDC 0121-1781-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-1781-05)

NDC 0121-1781-05

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

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

NDC Product Information

Childrens Acetaminophen with NDC 0121-1781 is a product labeled by Pharmaceutical Associates, Inc.. The generic name of Childrens Acetaminophen is . The product's dosage form is and is administered via form.

Labeler Name: Pharmaceutical Associates, 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.

Childrens Acetaminophen 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.

  • ACETAMINOPHEN 160 mg/5mL

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.

  • ACESULFAME (UNII: MA3UYZ6K1H)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • 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.
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
Start Marketing Date: 10-01-2014 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’.

* Please review the disclaimer below.

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 Acetaminophen Product Label Images

Childrens Acetaminophen 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

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily:reduces feverrelieves minor aches and pain due to:
  • The common coldfluheadachesore throattoothache

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 amountwith other drugs containing acetaminophen

Allergy Alert

  • Acetaminophen may cause severe skin reactions.  Symptoms may include:skin reddeningblistersrashIf 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.

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 pharmacist.if 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.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 children even if you do not notice any sign or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult usedo not take more than directed (see
  • Overdose warning)
  • Shake well before usingmL = milliliter; tsp = teaspoonfulfind the right dose on chart below. If possible, use weight to dose; otherwise, use agerepeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursWeight (lbs)Age (yr)Dose (mL or tsp)
  • Or as directed by a doctorUnder 24 Under 2 Ask a doctor24-352-3 years5 mL (1 tsp)36-474-5 years7.5 mL (1 ½ tsp)48-596-8 years 10 mL (2 tsp)60-719-10 years12.5 mL (2 ½ tsp)72-9511 years15 mL (3 tsp)

Other Information

  • Sodium content: 2 mg/5 mL store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]protect from freezinga red, berry flavored suspension supplied in the following oral dosage form:NDC 0121-1781-05:  5 mL unit dose cupNDC 0121-1781-00:  Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of 10 unit dose cups each.

Inactive Ingredients

Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Other

Pharmaceutical


Associates, Inc.


Greenville, SC 29605


www.paipharma.com


R01/17

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