Lil Drug Store Childrens Pain And Fever Suspension
FDA Label NDC 66715-6956

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Lil Drug Store Childrens Pain And Fever (NDC 66715-6956). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Product distributed by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE
Cedar Rapids, IA 52402

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

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 amount
  • with other drugs containing acetaminophen

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • If 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.

Otc - When Using

When using this product, do not exceed recommended dose (see Overdose warning).

Stop Use And Ask A Doctor If

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • These 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 (1-800-222-1222) right away. Quick medical attention is critical 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
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • Weight (lb)Age (year)Dose (mL)

    or as directed by a doctor

    under 24under 2ask a doctor
    24-352-35 mL
    36-474-57.5 mL
    48-596-810 mL
    60-719-1012.5 mL
    72-951115 mL

Other Information

  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive Ingredients

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions Or Comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Principal Display Panel - 118 Ml Bottle Carton

QUALITY
* GUARANTEED *

Compare to the Active Ingredient
in Children's Tylenol®
Oral Suspension**

Children's
Pain & Fever

Acetaminophen
160 mg per 5 mL
Pain Reliever/Fever Reducer

Oral Suspension
For ages 2-11 years

Cherry

4 FL OZ (118 mL)

Lil'
Drug Store®

Principal Display Panel (118 mL Bottle Carton)

Principal Display Panel (118 mL Bottle Carton)

* Please review the disclaimer below.