CHILDRENS IBUPROFEN
-
ibuprofen suspension
Actavis Mid Atlantic LLC
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Active ingredient (in each 5 mL = 1 teaspoon)
Ibuprofen 100 mg (NSAID)*
*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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.
The chances are higher if your child:
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.
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 (tsp or mL) |
under 2 years | ask a doctor | |
24 – 35 lbs | 2 – 3 years | 1 tsp or 5 mL |
36 – 47 lbs | 4 – 5 years | 1½ tsp or 7.5 mL |
48 – 59 lbs | 6 – 8 years | 2 tsp or 10 mL |
60 – 71 lbs | 9 – 10 years | 2½ tsp or 12.5 mL |
72 – 95 lbs | 11 years | 3 tsp or 15 mL |
Other information
Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.
Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.
Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C Red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.
Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.
Compare to the active ingredient in Children’s Motrin® Berry*
NDC 0472-1255-94
For ages 2 to 11
CHILDREN’S Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
See New Warnings Information
Original Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
ORIGINAL BERRY FLAVOR CARTON LABEL
Compare to the active ingredient in Children’s Motrin® Dye Free Berry*
NDC 0472-1261-94
For ages 2 to 11
CHILDREN’S Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
See New Warnings Information
Non-Staining
Dye-Free Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
DYE FREE BERRY FLAVOR CARTON LABEL
Compare to the active ingredient in Children’s Motrin® Grape*
NDC 0472-1262-94
For ages 2 to 11
CHILDREN’S Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
See New Warnings Information
Grape Flavor
Alcohol Free
4 FL OZ (118 mL)
GRAPE FALVOR CARTON LABEL
Compare to the active ingredient in Children’s Motrin® Bubble Gum*
NDC 0472-1263-94
For ages 2 to 11
CHILDREN’S Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL (teaspoon)
Pain Reliever
Fever Reducer
Lasts up to 8 hours
See New Warnings Information
Bubble Gum Flavor
Alcohol Free
4 FL OZ (118 mL)
BUBBLE GUM FLAVOR CARTON LABEL
CHILDRENS IBUPROFEN
ibuprofen suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA074916 | 06/01/2006 |
CHILDRENS IBUPROFEN
ibuprofen suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA074916 | 06/01/2006 |
CHILDRENS IBUPROFEN
ibuprofen suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA074916 | 06/01/2006 |
CHILDRENS IBUPROFEN
ibuprofen suspension |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA074916 | 06/01/2006 |
Labeler - Actavis Mid Atlantic LLC (809515898) |
Revised: 05/2010 Actavis Mid Atlantic LLC