Motrin ®

Motrin ®
SPL v9
SPL
SPL Set ID c2b99756-3e03-4d9f-9ce6-7db879afe3a1
Route
ORAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Fd&c Red No. 40 Aluminum Oxide Fd&c Yellow No. 6 Ferric Oxide Red Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Stearic Acid Talc Titanium Dioxide Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: MOT Shape: oval Color: orange Size: 16 mm Score: 1
Marketing Status
ANDA Completed Since 2022-11-29 Until 2028-08-08

Description

Drug Facts

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
adults and children 12 years and older
  • 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

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.

Other Information
  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

When Using This Product
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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
Ask A Doctor Before Use If
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the 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
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
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.

Active Ingredient (in Each Caplet)

Ibuprofen 200 mg (NSAID)

nonsteroidal anti-inflammatory drug

Motrin Ib 4ct Cvp Health Pdp/package

SEE REVISED WARNING

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplets image]

4

Coated Caplets**

2POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[CVP HEALTH logo]

Motrin Ib 6ct Travel Basix Pdp/package

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplets image]

6

Coated Caplets**

3POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[TRAVEL BASIX logo]

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
Principal Display Panel 200 Mg Tablet Pouch Carton

See Revised Warnings

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplet image]

4 Coated Caplets** 2 POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[Lil' Drug Store® logo]


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
adults and children 12 years and older
  • 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

Allergy Alert (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.

Other Information (Other information)
  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (Stomach bleeding warning)

This product contains an NSAID, which may cause severe stomach bleeding. The chances are 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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the 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
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
    • 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
Heart Attack and Stroke Warning (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.

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

Ibuprofen 200 mg (NSAID)

nonsteroidal anti-inflammatory drug

Motrin Ib 4ct Cvp Health Pdp/package (Motrin IB 4ct CVP HEALTH - PDP/Package)

SEE REVISED WARNING

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplets image]

4

Coated Caplets**

2POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[CVP HEALTH logo]

Motrin Ib 6ct Travel Basix Pdp/package (Motrin IB 6ct TRAVEL BASIX - PDP/Package)

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplets image]

6

Coated Caplets**

3POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[TRAVEL BASIX logo]

Ask A Doctor Or Pharmacist Before Use If You Are (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
Principal Display Panel 200 Mg Tablet Pouch Carton (PRINCIPAL DISPLAY PANEL - 200 mg Tablet Pouch Carton)

See Revised Warnings

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplet image]

4 Coated Caplets** 2 POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[Lil' Drug Store® logo]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)