NDC 0121-0939 Childrens Acetaminophen

Acetaminophen

NDC Product Code 0121-0939

NDC 0121-0939-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0939-05)

NDC Product Information

Childrens Acetaminophen with NDC 0121-0939 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Childrens Acetaminophen is acetaminophen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

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 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.

  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 01-29-2021 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 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.

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

Uses

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

Purpose

Pain reliever/fever reducer

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Other

Drug Facts

Manfactured ByPharmaceutical Associates, Inc.Greenville, SC 29605www.paipharma.com

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if • more than 5 doses in 24 hours, which is the maximum daily amount
  • • with 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 you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not exceed recommended dose (see


overdose warning)

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.

Otc - Keep Out Of Reach Of Children

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.

Directions

  • • this product does not contain directions or complete warnings for adult use
  • • do not take more than directed (see overdose warning)
  • • shake well before using
  • • mL = milliliter
  • • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • • repeat dose every 4 hours while symptoms last
  • • do not give more than 5 times in 24 hours
  • Weight (lb) Age (yr) Dose (mL)
  • *Under 24Under 2 yearsask a doctor24-352-3 years5 mL36-474-5 years7.5 mL48-596-8 years10 mL60-719-10 years12.5 mL72-9511 years15 mLOver 96adults and children 12 years and over20 mL

Other Information

  • Each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F) berry flavored suspension supplied in the following oral dosage forms:
  • NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.
  • NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

Acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Otc - Questions

Call 1-800-845-8210.

* Please review the disclaimer below.