Children's Ibuprofen Oral Suspension, Usp

Children's Ibuprofen Oral Suspension, Usp
SPL v1
SPL
SPL Set ID 3987b4e9-a7ac-420a-b040-91562972c9ee
Route
ORAL
Published
Effective Date 2017-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Yellow No. 10 Fd&c Red No. 40 Glycerin Hypromellose, Unspecified Polysorbate 80 Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 2006-06-01
Description

(in each 5 mL = 1 teaspoon) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

(in each 5 mL = 1 teaspoon) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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.

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.  If possible, use weight to dose; otherwise use age.
  • use only enclosed measuring cup
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
Dosing Chart
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

  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date
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
Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Active Ingredient

(in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Inactive Ingredient

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

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

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
Ask 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
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 the 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).

Principal Display Panel 100 Mg/5 Ml Bottle Label

Austin/Travis Co. Health & Human Services Dept.

1000 Toyath St Austin, TX 78702 512-972-6206

IBUPROFEN

100MG/5ML

SUSP.

Date:

Name:

Dr.

TAKE ___ ML BY MOUTH ___ TIMES A DAY.

05/2018

L606011

IBUPROFEN 100MG/5ML ORAL SUSP. #120 NDC 76413-344-01

Batch: 08301708

Lot: L606011

Exp: 05/2018

ACTAVIS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Ask Doctor Or Pharmacist Before Use If the Child Is
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses (USES)

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • shock
  • asthma (wheezing)
  • rash
  • skin reddening
  • blisters
  • facial swelling

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.

Directions (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.  If possible, use weight to dose; otherwise use age.
  • use only enclosed measuring cup
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
Dosing Chart
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

  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date
Do Not Use (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
Questions? (QUESTIONS?)

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Active Ingredient (ACTIVE INGREDIENT)

(in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Inactive Ingredient (INACTIVE INGREDIENT)

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

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

When Using This Product (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
Ask Doctor Before Use If (ASK 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
Stop Use and Ask A Doctor If (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 the 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 (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).

Principal Display Panel 100 Mg/5 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label)

Austin/Travis Co. Health & Human Services Dept.

1000 Toyath St Austin, TX 78702 512-972-6206

IBUPROFEN

100MG/5ML

SUSP.

Date:

Name:

Dr.

TAKE ___ ML BY MOUTH ___ TIMES A DAY.

05/2018

L606011

IBUPROFEN 100MG/5ML ORAL SUSP. #120 NDC 76413-344-01

Batch: 08301708

Lot: L606011

Exp: 05/2018

ACTAVIS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Ask Doctor Or Pharmacist Before Use If the Child Is (ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.821474 · Updated: 2026-03-14T22:54:51.534540