Active Ingredients And Purpose
Active ingredient (in each white tablet)
Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Leader 44-438
- Manufacturer
- Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
- Effective date
- 2026-06-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- daily-update
- Hydrated at
- 2026-06-18 05:10:09
Key Label Information#
Uses
Uses
temporarily relieves minor aches and pains due to: muscular aches backache toothache menstrual cramps headache the common cold minor pain of arthritis temporarily reduces fever
Warnings
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: rash facial swelling asthma (wheezing) hives skin reddening 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 take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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 And Dosage
Directions
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: 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 Label Information
Other information
store between 20º-25ºC (68º-77ºF) avoid excessive heat 40ºC (104ºF) see end flap for expiration date and lot number
Inactive ingredients
colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
LEADER ™ NDC 70000-0291-1 Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID) 100 TABLETS ACTUAL SIZE 100% Money Back Guarantee Leader 44-438
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0291-1 | EA - Each | 70000-0291 | 2d8520ac-6b4c-49e1-901e-23fa95d67ead | 1 | 2019-06-19 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0291 | 70000-0291-1 |
Ingredients#
Complete SPL Sections#
Active ingredient (in each white tablet)
Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to: muscular aches backache toothache menstrual cramps headache the common cold 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: rash facial swelling asthma (wheezing) hives skin reddening 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 take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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 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
store between 20º-25ºC (68º-77ºF) avoid excessive heat 40ºC (104ºF) see end flap for expiration date and lot number
Inactive ingredients
colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
LEADER ™ NDC 70000-0291-1 Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID) 100 TABLETS ACTUAL SIZE 100% Money Back Guarantee Leader 44-438
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2025-06-12 | full-release | 2026-06-01 01:02:58 |