Ibuprofen, Lil Drug Store

Manufacturer
Lil' Drug Store products, Inc.
Effective date
2024-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:01

Label at a glance#

ProductIbuprofen, Lil Drug Store
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Dosage and administration

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Drug facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Ibuprofen Tablet USP, 200 mg ( NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Allergy alert

SPL UNCLASSIFIED SECTION

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this produc

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better.
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

​Other information

  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

​Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

​Questions or comments?​

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

Ibuprofen, Lil' Drug Store ®, 12ct Vial - PDP/Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY GUARANTEED

Compare to the Active
Ingredient in Advil® Tablets**

Ibuprofen

Tablets USP, 200 mg (NSAID)

Pain Reliever/Fever Reducer

12
Tablets

[Lil' Drug Store® logo]

OPEN HERE FOR DRUG FACTS INFORMATION

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN1
310965ibuprofen 200 MG Oral TabletSCD1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9839-4Ibuprofen, Lil Drug Store12 in 1 VIAL, PLASTICTABLET, FILM COATED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9839IBUPROFEN, LIL DRUG STORE (IBUPROFEN) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 1 package rows20240530_18e80dab-6837-fd2d-e063-6294a90a73c8.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
66715-983966715-9839-4

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
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsExact identifier
ndc (package): 66715-9839-4
ndc (product): 66715-9839
ndc11 (package): 66715983904
spl id: 18e80dab-6838-fd2d-e063-6294a90a73c8
spl set id: 18e80dab-6837-fd2d-e063-6294a90a73c8

Reported adverse events (FAERS/openFDA)#

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