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spl product data elements
JUNIOR STRENGTH ADVIL ibuprofen IBUPROFEN IBUPROFEN ASPARTAME CELLACEFATE SILICON DIOXIDE D&C RED NO. 30 FD&C BLUE NO. 2 GELATIN, UNSPECIFIED MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO light purple mottled round purple tablet Advil;100
活性成分 / Active ingredient
ACTIVE INGREDIENT (IN EACH TABLET) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
用途 / Purpose
PURPOSE Fever reducer/Pain reliever
适应证 / Indications and usage
USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
警告 / Warnings
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 an NSAID, which may cause severe stomach bleeding. The chance is higher if the child • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • takes 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. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child is taking a diuretic Ask a doctor or pharmacist before use if the child is • under a doctor's care for any serious condition • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • child has symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
禁用事项 / Do not use
Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
咨询医生 / Ask a doctor
Ask a doctor before use if • stomach bleeding warning applies to the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child is taking a diuretic
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if the child is • under a doctor's care for any serious condition • taking any other drug
使用中 / When using
When using this product • take with food or milk if stomach upset occurs
停用事项 / Stop use
Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • child has symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear
儿童安全 / 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.
用法用量原文 / Dosage and administration
DIRECTIONS • this product does not contain directions or complete warnings for adult use • do not give more than directed • find right dose on chart. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Dose (tablets) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 1 tablet 36-47 lb 4-5 yr 1 ½ tablets 48-59 lb 6-8 yr 2 tablets 60-71 lb 9-10 yr 2 ½ tablets 72-95 lb 11 yr 3 tablets
dosage and administration table
<table ID="_Reftable1" width="60%"><caption>Dosing Chart</caption><col width="20%"/><col width="19%"/><col width="21%"/><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Weight (lb)</content></th><th align="left" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Age (yr)</content></th><th align="left" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Dose (tablets)</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>under 24 lb</paragraph></td><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph>under 2 yr</paragraph></td><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>24-35 lb</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>2-3 yr</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>1 tablet</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>36-47 lb</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>4-5 yr</paragraph></td><td styleCode="Rrule Botrule " valign="top"><paragraph>1 ½ tablets</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>48-59 lb</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>6-8 yr</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2 tablets</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>60-71 lb</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>9-10 yr</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2 ½ tablets</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule " valign="middle"><paragraph>72-95 lb</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>11 yr</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>3 tablets</paragraph></td></tr></tbody></table>
spl unclassified section
OTHER INFORMATION • Phenylketonurics : contains phenylalanine 4.2 mg per tablet • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see side of box for lot number and expiration date
辅料 / Inactive ingredients
INACTIVE INGREDIENTS aspartame, cellacefate, colloidal silicon dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, modified corn starch, natural and artificial flavors, sodium starch glycolate
questions
QUESTIONS OR COMMENTS? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
package label principal display panel
PRINCIPAL DISPLAY PANEL Junior Strength Advil ® Chewables Ibuprofen Tablets, 100 mg Pain Reliever/Fever Reducer (NSAID) FEVER Aches & Pains NEW! Now for Ages 2-11 LASTS UP TO 8 HOURS Grape 24 Chewable Tablets Principal Display Panel - 100 mg Tablet Bottle Carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 9 / 20250627
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

