Childrens Ibuprofen IBUPROFEN HARRIS TEETER, LLC FDA Approved USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA210149
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (in each 5 mL) Ibuprofen USP 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
INACTIVE INGREDIENTS anhydrous citric acid D&C yellow no. 10 FD&C red no. 40 flavor glycerin polysorbate 80 pregelatinized starch purified water sodium benzoate sucrose xanthan gum
Strengths
5 ml 100 mg
Quantities
5 ml 120 ml
Treats Conditions
Use S Temporarily Relieves Minor Aches And Pains Due To The Common Cold Flu Sore Throat Headache And Toothache Reduces Fever
Pill Appearance
Color: orange

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children's Motrin ® * Harris Teeter™ NDC 69256-634-03 Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL PAIN RELIEVER/FEVER REDUCER For Ages 2 to 11 Years Lasts up to 8 Hours Alcohol Free Mixed Berry Flavor 4 FL OZ (120 mL) 634-4-ht.jpg

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children's Motrin ® * Harris Teeter™ NDC 69256-634-03 Children's Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL PAIN RELIEVER/FEVER REDUCER For Ages 2 to 11 Years Lasts up to 8 Hours Alcohol Free Mixed Berry Flavor 4 FL OZ (120 mL) 634-4-ht.jpg

Overview

USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Indications & Usage

USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Dosage & Administration

DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL=milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor

Warnings & Precautions
WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening facial swelling shock 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.
Purpose

PURPOSE Pain reliever/fever reducer

Do Not Use

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

When Using

WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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

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)

Storage & Handling

OTHER INFORMATION each 5 mL contains: sodium 2 mg store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.


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