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Drug Facts
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE ROAD., MATTHEWS, NC 28105
The following Structured Product Label (SPL) was submitted to the FDA by Family Wellness for the product Childrens Ibuprofen (NDC 55319-150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE ROAD., MATTHEWS, NC 28105
Ibuprofen 100 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:
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.
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
Ask a doctor before use if
Ask a doctor or pharmacist before use if the child is
When using this product
Stop use and ask a doctor if
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)
| Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
|---|---|---|
| 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 |
acesulfame potassium, berry flavor natural & artificial, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sucrose, xanthan gum
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COMPARE TO THE ACTIVE
INGREDIENT IN CHILDREN'S
MOTRIN® DYE-FREE BERRY FLAVOR***
FAMILY
wellness™
NDC 55319-150-08
100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED
See New Warnings
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
8
HOUR
RELIEF
BERRY FLAVOR
Dye-Free, Alcohol Free
4 FL OZ (120 mL)
* Please review the disclaimer below.