Label: IBUPROFEN ORAL- ibuprofen oral suspension
- NDC Code(s): 63629-8852-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 69230-310
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT(S)(in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
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PURPOSEPain reliever/fever reducer
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USE(S)temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache - reduces fever
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WARNINGSAllergy 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 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 better - child has symptoms of heart ...
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KEEP OUT OF REACH OF CHILDRENIn 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 ...
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Other information each 5 mL contains : sodium 2 mg - store between 20-25°C (68-77°F) do not use if carton is opened or printed bottle neckband is broken or missing - see bottom panel for lot ...
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INACTIVE INGREDIENT SECTIONBerry flavor (with dye) Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate ...
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QUESTIONS SECTIONCall 1-888-588-1418 from 9 AM to 5 PM EST, Monday-Friday. Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA ...
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HOW SUPPLIED
NDC: 63629-8852-1: 118 mL in a BOTTLE - Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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PRINCIPAL DISPLAY PANELIbuprofen Suspension Bubble gum #118
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INGREDIENTS AND APPEARANCEProduct Information