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spl product data elements
CHILDRENS IBUPROFEN Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM GRAPE ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2208 (4000 MPA.S) POLYSORBATE 80 STARCH, POTATO PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM Light purple to purple
活性成分 / Active ingredient
Drug Facts Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*
用途 / Purpose
Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
适应证 / Indications and usage
Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
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 your 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.
禁用事项 / Do not use
Do not use if the child has ever had an allergic reaction to ibuprofen or 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma 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 the 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. (1-800-222-1222)
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 shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6 to 8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance wash dosage cup after each use Dosing Chart * or as directed by a doctor Weight (lb) Age (year) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL
dosage and administration table
<table cellspacing="0" cellpadding="0" border="0" width="100%"><caption>Dosing Chart </caption><colgroup><col width="32.48%"/><col width="33.76%"/><col width="33.76%"/></colgroup><tfoot><tr><td colspan="3" align="justify">* or as directed by a doctor </td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle"><content styleCode="bold">Weight (lb)</content> </td><td styleCode="Rrule" align="center" valign="middle"><content styleCode="bold">Age (year)</content> </td><td styleCode="Rrule" align="center" valign="middle"><content styleCode="bold">Dose (mL)*</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">under 24 </td><td styleCode="Rrule" align="center" valign="middle">under 2 years </td><td styleCode="Rrule" align="center" valign="middle">ask a doctor </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">24-35 lbs </td><td styleCode="Rrule" align="center" valign="middle">2-3 years </td><td styleCode="Rrule" align="center" valign="middle">5 mL </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">36-47 lbs </td><td styleCode="Rrule" align="center" valign="middle">4-5 years </td><td styleCode="Rrule" align="center" valign="middle">7.5 mL </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">48-59 lbs </td><td styleCode="Rrule" align="center" valign="middle">6-8 years </td><td styleCode="Rrule" align="center" valign="middle">10 mL </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">60-71 lbs </td><td styleCode="Rrule" align="center" valign="middle">9-10 years </td><td styleCode="Rrule" align="center" valign="middle">12.5 mL </td></tr><tr><td styleCode="Lrule Rrule" align="center" valign="middle">72-95 lbs </td><td styleCode="Rrule" align="center" valign="middle">11 years </td><td styleCode="Rrule" align="center" valign="middle">15 mL </td></tr></tbody></table>
储存 / Storage and handling
Other information each 5 mL contains : sodium 2 mg store between 20 to 25°C (68 to 77°F) do not use if carton is opened or seal under cap opening is broken or missing see bottom panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients Acesulfame potassium, art grape flavor, citric acid anhydrous, D&C Red No. 33, FD&C blue No. 1, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum Questions or comments? Call 1-855-274-4122 Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Made in India Code: TS/DRUGS/19/1993
package label principal display panel
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label NDC 58602-003-24 For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label NDC 58602-003-24 # Compare to the active ingredient in Children's Motrin ® For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Grape Flavor 4 FL OZ (120 mL) AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (120 mL) Carton Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20250901
- 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.

