NDC 69517-628 Acetaminophen

NDC Product Code 69517-628

NDC 69517-628-17

Package Description: 1 BOTTLE in 1 CARTON > 15 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

Acetaminophen with NDC 69517-628 is a product labeled by Healthlife Of Usa. The product's dosage form is and is administered via form.

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 POTASSIUM (UNII: 23OV73Q5G9)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • 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: Healthlife Of Usa
Labeler Code: 69517
Start Marketing Date: 01-09-2018 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: 12-31-2019 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 - INACTIVATED, the listing data was inactivated by the FDA. 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.

Acetaminophen Product Label Images

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 5Ml)

Acetaminophen 160mg

Purpose

Fever reducer/ pain reliever

Uses

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

Warnings

  • 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 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.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.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whetgher 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

Ask A Doctor Before Use If Your Child Has

Liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

Taking the blood thinning drug warfarin

(See overdose warning)

Stop Use And Ask A Doctor If

  • New symptoms occurredness or swelling is presentpain gets worse or lasts more than 5 daysfever gets worse or lasts more than 3 daysThese could be signs of a serious condition

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away. 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 usemL=mililiterfind right dose on chart below. If possible, use weight to dose; otherwise, use age.fill to dose level. Do not use any other dosing devicedispense liquid slowly into child's mouth, toward inner cheekrepeat dose every 4 hours while symptoms lastrinse the dosing device after each usedo not give more than 5 times in 24 hoursshake well before usedo not give moer than directed.Weight (lb)Age (year)Dose (mL)*Under 24Under 2 years Ask a doctor24-352-35mL* or as directed by a doctorAttention: Use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • Store between 15°-30°C (59°-86°F)Protect from freezingProtect from light

Inactive Ingredients

Acesulfame Potassium, Avicel, Butyl paraben, citric acid, FD&C Red #33, FD&C Blue #1, Glycerin, High fructose corn syrup, Nat grape flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucralose, Prosweet N and A, Purified water, xanthan gum

Infant's Acetaminophen Oral Suspension Pain Reliever/ Fever Reducer

Distributed by:Healthlife of USA1600 Hart Street, Rahway, NJ 07065www.healthlifeofusa.com

* Please review the disclaimer below.