Drugplain

topcare ibuprofen 200 mg/1

ibuprofen · CAPSULE, LIQUID FILLED · Topco Associates LLC

No Recall History
Plain English

topcare ibuprofen is a capsule, liquid filled containing ibuprofen at 200 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
topcare ibuprofen
Generic Name
ibuprofen
NDC Code (Product)
36800-705
Manufacturer
Topco Associates LLC
Strength
200 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
ANDA203599
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
09/24/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15,477 reports
pain14,869 reports
fatigue14,244 reports
nausea13,254 reports
headache11,918 reports
arthralgia10,747 reports
dyspnoea10,352 reports
vomiting9,802 reports
diarrhoea9,538 reports
rash8,899 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Dosage & Administration

Directions • do not take more than directed • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours

Warnings

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 • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or non-prescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take 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. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • unless you have time for a full night’s sleep • in children under 12 years of age • right before or after

Frequently Asked Questions

What is topcare ibuprofen used for?

topcare ibuprofen contains ibuprofen. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is topcare ibuprofen a controlled substance?

topcare ibuprofen is not classified as a controlled substance by the DEA.

What is the generic name for topcare ibuprofen?

The generic name for topcare ibuprofen is ibuprofen. There are 12 other brand versions of ibuprofen.

What is the NDC code for topcare ibuprofen 200 mg/1?

The NDC (National Drug Code) for topcare ibuprofen 200 mg/1 is 36800-705, listed by Topco Associates LLC.