Label: CHILDRENS IBUPROFEN- ibuprofen suspension
- NDC Code(s): 21130-216-20
- Packager: Better Living Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 28, 2025
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*
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Purpose
Pain reliever/fever reducer - *nonsteroidal anti-inflammatory drug
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Uses
temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache - reduces fever
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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 ...
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Do not useif the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer - right before or after heart surgery
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Ask a doctor before use ifstomach 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 ...
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Ask a doctor or pharmacist before use if the child isunder a doctor's care for any serious condition - taking any other drug
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When using this producttake with food or milk if stomach upset occurs
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Stop use and ask a doctor ifchild 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 ...
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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)
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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 ...
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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 ...
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Inactive ingredients
Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Container LabelNDC 21130-216-20 - Signature - care® Quality - Guranteed - FOR - AGES 2 to 11 YEARS - Children’s - Ibuprofen - ORAL SUSPENSION USP - 100 mg per 5 mL - Pain Reliever/Fever ...
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Carton LabelCompare to - Children's Motrin® active ingredient** NDC 21130-216-20 - Signature - care® Quality - Guranteed - FOR - AGES 2 TO 11 YEARS - Children’s - Ibuprofen - ORAL SUSPENSION ...
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INGREDIENTS AND APPEARANCEProduct Information