DZA Brands, LLC Ibuprofen Oral Suspension Drug Facts

healthy accents ibuprofen by

Drug Labeling and Warnings

healthy accents ibuprofen by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS IBUPROFEN INFANTS- ibuprofen suspension 
DZA Brands LLC

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DZA Brands, LLC Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 reddening
• rash
• blisters

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:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• takes more or for a longer time 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.

Do not use

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if

• stomach 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 reducers
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
• child has asthma
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

• under a doctor’s care for any serious condition
• taking any other drug

When using this product

• give with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• child 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
• the child does not get any relief within first day (24 hours) of treatment
• fever or pain gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

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)

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• measure with the dosing device provided. Do not use with any other device.
• dispense liquid slowly into the child’s mouth, toward the inner cheek
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day

Dosing Chart
Weight (lbs)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lbs	6-11 mos	1.25 mL
18-23 lbs	12-23 mos	1.875 mL

Other information

• store at 20-25°C (68-77°F)
• do not freeze
• do not use if printed neckband is broken or missing
• see bottom of box for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-866-322-2439

Principal Display Panel

for ages 6 mos. to 23 mos.

infants'

ibuprofen oral suspension

50mg per 1.25mL

pain reliever - fever reducer (NSAID)

concentrated drops

lasts up to 8 hours

Compare to Motrin® Infants' Drops Berry Flavor active ingredient

berry flavor

½ FL OZ (15mL)

USE ONLY WITH ENCLOSED SYRINGE

gluten free

HEALTHY ACCENTS IBUPROFEN  INFANTS
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	50 mg  in 1.25 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	PINK (light)	Score
Shape		Size
Flavor	FRUIT (mixed)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-057-05	1 in 1 CARTON	02/18/2008	08/13/2019
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075217	02/18/2008	08/13/2019

Labeler - DZA Brands LLC (090322194)

Revised: 11/2019

Document Id: d77d46c0-6960-4f71-9f59-cbb88bc166c4

34390-5

Set id: 4023fb65-10c0-4602-bd3c-f8f6c86fc93a

Version: 3

Effective Time: 20191112