Lil Drug Store Childrens Pain and Fever

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:29

Label at a glance#

ProductLil Drug Store Childrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

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 direct...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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 SECTION

Ask a doctor before use if your child has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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) *
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

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6956-4Lil Drug Store Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
66715-6956-4Lil Drug Store Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6956LIL DRUG STORE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20241222_5fcd41ad-449f-4090-be19-eae4171de891.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-695666715-6956-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
ndc (package): 66715-6956-4
ndc (product): 66715-6956
ndc11 (package): 66715695604
spl id: 296a576d-1b6a-d363-e063-6294a90ac829
spl set id: 5fcd41ad-449f-4090-be19-eae4171de891

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.