Drug Facts
Active ingredient (in each 5 mL)
Ibuprofen USP 100 mg (NSAID)*
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Childrens Ibuprofen (NDC 21130-216). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each 5 mL)
Ibuprofen USP 100 mg (NSAID)*
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
temporarily:
Allergy alert: 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:
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.
• feels faint
• vomits blood
• has bloody or black stools
• has stomach pain that does not get better
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| † 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 |
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 starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum
Questions or comments?
Call 1-855-274-4122
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99, PLEASANTON
CA 94566-0009
‡1-888-723-3929
Made in India
NDC 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 Reducer
(NSAID)
• Lasts up to 8 hours
• Alcohol free
BERRY FLAVOR
8 FL OZ (240 mL)
Compare 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 USP
100 mg per 5 mL
Pain Reliever/Fever Reducer
(NSAID)
BERRY
FLAVOR
• Lasts up to 8 hours
• Alcohol free
Use ONLY enclosed
dosage cup
8 FL OZ (240 mL)
* Please review the disclaimer below.