NDC 70005-049 Childrens Acetaminophen

NDC Product Code 70005-049

NDC 70005-049-01

Package Description: 60 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 Acetaminophen with NDC 70005-049 is a product labeled by We Care Distributor Inc.. The generic name of Childrens Acetaminophen is . The product's dosage form is and is administered via form.

Labeler Name: We Care Distributor 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: We Care Distributor Inc.
Labeler Code: 70005
Start Marketing Date: 10-13-2016 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: 12-31-2018 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 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)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Uses

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

Liver Warning:

  • This product contains acetaminophen. Severe liver damage may occur if your child takesmore 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.

Do Not Use

  • With any other drug containing acetaminophen (prescription or non-prescription). 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

Otc - When Using

When using this product do not exceed recommended dose (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.

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. 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.shake well before usingmL = milliliterfind right dose on chart below. If possible, use weight to dose; otherwise, use age.repeat dose every 4 hours while symptoms lastdo not give more than 5 times in 24 hoursdo not give more than 5 days unless directed by a doctorWeight (lb.)      Age(yrs.)      Dose (mL*)Under 24           Under 2       Ask a doctor24-35                  2-3                 5 mL36-47                  4-5                 7.5 mL48-59                  6-8                 10 mL60-71                  9-10               12.5 mL72-95                  11                  15 mL* always check with your doctor before administering medicine to your infant/child

Other Information

  • Each teaspoon (5 mL) contains: sodium 7 mgStore at room temperature 15º - 30ºC (59º - 86ºF)Protect from Freezing.Protect from Light.TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive Ingredients

Citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

* Please review the disclaimer below.