Active Ingredients And Purpose
Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)
Purpose
Pain reliever/fever reducer
VALUMEDS IBUPROFEN TABLETS
- Set ID
- a6d4ceb0-2b79-496a-aa1e-27edd507ced0
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:06
Key Label Information
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
Warnings
WARNINGS SECTION
Warnings
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 if
the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic
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
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
read all warnings and directions before use store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F)
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL- 200 mg 100 ct Bottle
VALUMEDS IBUPROFEN TABLETS USP, 200MG PAIN RELEIVER/ FEVER REDUCER (NSAID) 100 TABLETS (COATED BROWN)
Products
- VALUMEDS IBUPROFEN
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)
Purpose
Pain reliever/fever reducer
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 SECTION
Warnings
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
This product contains a nonsteroidal anti-inflammatory drug (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
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 if
the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic
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 product
take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear
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 during the last 3 months of pregnancy unless definitely 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
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
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
read all warnings and directions before use store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F)
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL- 200 mg 100 ct Bottle
VALUMEDS IBUPROFEN TABLETS USP, 200MG PAIN RELEIVER/ FEVER REDUCER (NSAID) 100 TABLETS (COATED BROWN)
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/a6d4ceb0-2b79-496a-aa1e-27edd507ced0/28ed10e2-9113-a062-e063-6394a90a0ba3.xml
- XML SHA-256
- d624bbfd4c6e96705a596358570fb1cde086f5dc1883d37c40d30bf4b1f0d81a
- XML bytes
- 31778
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 28ed10e2-9113-a062-e063-6394a90a0ba3.xml | 2024-12-12 |
| otc | 0c05e920-ff9e-7bd4-e063-6294a90aad3e.xml | 2023-12-09 |
| otc | eea010c2-194b-029c-e053-2a95a90ad4cf.xml | 2022-11-30 |
| otc | d04ede6b-ba50-828d-e053-2995a90abdc2.xml | 2021-11-09 |
| otc | b60c16e6-44b8-5c37-e053-2a95a90a3b26.xml | 2020-12-10 |
| otc | 93397620-f343-1644-e053-2995a90a5c28.xml | 2019-09-24 |
| otc | VM Ibuprofen Tablets 200 mg 100ct_941-01.jpg | 2019-09-24 |