INFANTS ADVIL description, usages, side effects, indications, overdosage, supplying and lots more!

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INFANTS ADVIL

Pfizer Consumer Healthcare

INFANT'S ADVIL CONCENTRATED DROPSINFANT'S ADVIL CONCENTRATED DROPS (Dye-Free)(Ibuprofen)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Ibuprofen 50 mg (NSAID)nonsteroidal anti-inflammatory drug

Fever reducer/Pain reliever

temporarily:

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

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 the 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

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 the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • 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

  • take 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
  • 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.

  • 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.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day
  • measure with the dosing device provided. Do not use with any other device.
Dosing Chart
Weight (lb) Age (mos) Dose (mL)
under 6 mos ask a doctor
12-17 lb 6-11 mos 1.25 mL
18-23 lb 12-23 mos 1.875 mL
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date

acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

For most recent product information, visit www.Advil.com.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Infants'
Advil
®
Concentrated Drops
Fever Reducer / Pain Reliever (NSAID)

White Grape-Flavored Drops
1 FL OZ (30 mL)

INFANTS ADVIL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

New VALUE Size

Infants'
Advil
®
Concentrated Drops

Ibuprofen 50 mg Fever Reducer/
Pain Reliever (NSAID) per 1.25 mL

Fever

Aches & Pains

Lasts Up To
8
Hours

Dye-Free

White Grape Flavored Drops
for ages 6–23 months

1 FL OZ (30 mL)
Alcohol-Free

INFANTS ADVIL

INFANTS ADVIL

ibuprofen SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-0191
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 50 mg

Inactive Ingredients

Ingredient Name Strength
ACETIC ACID
BUTYLATED HYDROXYTOLUENE
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
GLYCERIN
cellulose, microcrystalline
polysorbate 80
propylene glycol
water
SODIUM BENZOATE
sorbitol
SUCROSE
XANTHAN GUM

Product Characteristics

Color
WHITE (Translucent off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 30 in 1 BOTTLE, DROPPER
3 NDC:0573-0191-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020812 1998-01-30


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Be sure to consult your doctor before taking any medication!
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