MedPath

Direct Safety Ibuprofen

Direct Safety Ibuprofen

Approved
Approval ID

28d45743-d298-29db-e054-00144ff8d46c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Conney Safety Products, LLC

DUNS: 023316151

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61245-085
Application NumberANDA075010
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (14)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/13/2020

Direct Safety Ibuprofen Label

Direct Safety®

Ibuprofen

Pain Reliever/Fever reducer

Ibuprofen 200 mg. (NSAID)

Ibuprofeno 200 mg. (AINE)

This Package is for Households without Young Children.

Pull To Open

Tire Para Abrir

Industrial Pack 500

(250 Packets of 2 Tablets)

DS Ibuprofen

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/1/2016

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/1/2016

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/1/2016

Active ingredient

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/1/2016

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 2/1/2016

Warnings

Alergy alert:

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

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

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

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:

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 2/1/2016

Do not use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 3/13/2020

Ask a doctor before use if

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ stomach bleeding warning applies to you

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 2/1/2016

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 3/13/2020

When using this product

■ take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 3/13/2020

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 for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 2/1/2016

If pregnant or breast feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/1/2016

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/1/2016

Directions

■** do not use more than directed**

■ the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

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:

Do not give to children under 12 years of age.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/1/2016

Other information

■ read all product information before using

■ store at 68-77°F (20-25°C)

■ avoid excessive heat 40°C (above 104°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/1/2016

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/1/2016

Questions or comments?

1-800-356-9100

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Direct Safety Ibuprofen - FDA Drug Approval Details