Family Wellness 44-393

Family Wellness 44-393
SPL v3
SPL
SPL Set ID 89ed9311-2185-4660-b219-9ea67b1a71ec
Route
ORAL
Published
Effective Date 2025-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Starch, Corn Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;393 Shape: oval Color: orange Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2023-12-13

Description

Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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

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

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

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

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

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.

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Family

Wellness™

COMPARE TO THE

ACTIVE INGREDIENT IN

MOTRIN® IB CAPLETS

IBUPROFEN

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

ACTUAL SIZE

Film Coated Caplets**

**CAPSULE-SHAPED TABLETS

100 COATED CAPLETS

NDC 55319-893-12

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Motrin® IB Caplets.

50844      ORG122139312

DISTRIBUTED BY: MIDWOOD BRANDS LLC,

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

• 100% SATISFACTION •



OR YOUR MONEY BACK!

NOT 100% SATISFIED?

Return within 30 days to the store

of purchase for a refund (with

receipt) or exchange.

Family Wellness 44-393
When Using This Product
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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
    • weakness in one part or side of body
    • slurred speech
    • trouble breathing
    • 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,

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.

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

Active Ingredient (in Each Orange Caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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 

Structured Label Content

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

Pain reliever/fever reducer

Warnings

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

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

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

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

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.

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Family

Wellness™

COMPARE TO THE

ACTIVE INGREDIENT IN

MOTRIN® IB CAPLETS

IBUPROFEN

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

ACTUAL SIZE

Film Coated Caplets**

**CAPSULE-SHAPED TABLETS

100 COATED CAPLETS

NDC 55319-893-12

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Kenvue

Inc., owner of the registered trademark Motrin® IB Caplets.

50844      ORG122139312

DISTRIBUTED BY: MIDWOOD BRANDS LLC,

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

• 100% SATISFACTION •



OR YOUR MONEY BACK!

NOT 100% SATISFIED?

Return within 30 days to the store

of purchase for a refund (with

receipt) or exchange.

Family Wellness 44-393
When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
Stop Use and Ask A Doctor If (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
    • weakness in one part or side of body
    • slurred speech
    • trouble breathing
    • 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, (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. (Keep out of reach of children.)

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

Active Ingredient (in Each Orange Caplet) (Active ingredient (in each orange caplet))

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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 

Advanced Ingredient Data


Raw Label Data

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