Concentrated Ibuprofen Infants: Package Insert and Label Information

CONCENTRATED IBUPROFEN INFANTS — ibuprofen suspension/ drops
Guardian Drug Company

ACTIVE INGREDIENT (in each 1.25 mL)

Ibuprofen, USP 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

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 you 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

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.

DO NOT USE

  • if the child has ever had an allergic reaction to ibuprofen or 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, kidney disease or had a stroke
  • 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

  • take with food or milk if stomach upset occurs

STOP USE AND ASK 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 has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of the body
  • slurred speech
  • leg swelling
  • 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.
  • mL=milliliter
  • measure with dosing device provided. Do not use any other dosing 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 (lb) AGE (mos) DOSE (mL)
under 6 mos ask a doctor
12-17 lbs 6-11 mos 1.25 mL
18-23 lbs 12-23 years 1.875 mL

OTHER INFORMATION

  • store between 20-25o C (68-77o F)
  • do not use if carton is opened or if printed neckband is imprinted with “SEALED FOR YOUR PROTECTION” and “USE WITH ENCLOSED DOSING DEVICE ONLY” is broken or missing.

INACTIVE INGREDIENTS

anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

QUESTIONS OR COMMENTS?

call 1-609-860-2600 (Monday — Friday 8 am — 4 pm)

PRINCIPAL DISPLAY PANEL

NDC 53041-637-09
See New Warnings

For Ages 6 mos. to 23 mos.
Concentrated Infants’ Drops
IBUPROFEN
Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer
(NSAID)
Lasts up to 8 Hours
Dye-Free
Berry Flavor
1 fl oz (30 mL)GUARDIAN

637-GDC-1
(click image for full-size original)
CONCENTRATED IBUPROFEN INFANTS ibuprofen suspension/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53041-637
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg in 1.25 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
GLYCERIN
POLYSORBATE 80
STARCH, CORN
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor BERRY (Mixed Berry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53041-637-09 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (53041-637-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210755 10/03/2018
Labeler — Guardian Drug Company (119210276)
Establishment
Name Address ID/FEI Operations
Guardian Drug Company 119210276 MANUFACTURE (53041-637)

Revised: 11/2022 Guardian Drug Company

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