NDC 0121-0657 Acetaminophen


NDC Product Code 0121-0657

NDC 0121-0657-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0657-05)

NDC 0121-0657-11

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10.15 mL in 1 CUP, UNIT-DOSE

NDC 0121-0657-21

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 20.3 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Acetaminophen with NDC 0121-0657 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is solution and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SUCROSE (UNII: C151H8M554)

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: 08-01-2007 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: 12-31-2021 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".

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Information for Patients


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]

* Please review the disclaimer below.

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


Drug Facts

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg


Pain reliever/fever reducer


  • Temporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual and menstrual crampstemporarily reduces fever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you take:adult takes more than 6 doses in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Allergy Alert

  • Acetaminophen may cause severe skin reactions.  Symptoms may include:
  • Skin reddening blisters rashIf 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.for more than 10 days for pain unless directed by a doctorfor more than 3 days for fever unless directed by a doctorif you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask A Doctor Before Use If You Have

  • Liver disease

Ask A Doctor Or Pharmacist Before Use If

  • You are taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • Symptoms do not improvenew symptoms occurpain or fever persists or gets worse

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. 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 signs or symptoms.


  • Do not take more than directed (see
  • Overdose warning)
  • Agedoseadults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours
  • Not to exceed 6 doses in a 24-hour period
  • Children 6 to under 12 years of age10.15 mL (325 mg) every 4 hours
  • Not to exceed 5 doses in a 24-hour period
  • Children 4 to under 6 years of age7.5 mL (240 mg) every 4 hours
  • Not to exceed 5 doses in a 24-hour period
  • Children 2 to under 4 years of age5 mL (160 mg) every 4 hours
  • Not to exceed 5 doses in a 24-hour period
  • Children under 2 years of ageconsult a doctor

Other Information

sodium content: 2 mg/5 mL 

■ store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]■ keep tightly closed  ■ protect from light■ a red, cherry flavored solution supplied in the following oral dosage forms:NDC 0121-0657-05:  5 mL unit dose cupNDC 0121-0657-00:   Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.NDC 0121-1314-11:  10.15 mL unit dose cupNDC 0121-1314-00:   Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.NDC 0121-1971-21:  20.3 mL unit dose cupNDC 0121-1971-00:   Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.

Inactive Ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Manufactured By:

Pharmaceutical Associates, Inc.Greenville, SC 29605


* Please review the disclaimer below.