Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg IBUPROFEN DIPHENHYDRAMINE CITRATE PLD ACQUISITIONS LLC DBA AVMA PHARMA SOLUTIONS FDA Approved Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA211404

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive Ingredients carnauba wax corn starch croscarmellose sodium FD&C blue #2 hypromellose microcrystalline cellulose polydextrose polyethylene glycol 400 silicon dioxide stearic acid titanium dioxide
Strengths
38 mg 200 mg
Treats Conditions
Uses For Relief Of Occasional Sleeplessness When Associated With Minor Aches And Pains Helps You Fall Asleep And Stay Asleep
Pill Appearance
Shape: oval Color: blue Imprint: PL72

Identifiers & Packaging

Container Type BOX
UPC
0000000000000
UNII
4OD433S209 WK2XYI10QM
Packaging

Principal Display Panel †Compare to the active ingredients in Advil®PM Caplets Ibuprofen and Diphenhydramine Citrate Tablets 200 mg/ 38 mg Pain reliever (NSAID) /Nighttime sleep-aid 20 Coated caplets** (**Capsule-shaped tablets) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Caplets. Manufactured by: Avéma Pharma Solutions 10400 NW 29th Terrace, Miami, FL 33172; Product Packaging 20ct FC004635 V3

Package Descriptions
  • Principal Display Panel †Compare to the active ingredients in Advil®PM Caplets Ibuprofen and Diphenhydramine Citrate Tablets 200 mg/ 38 mg Pain reliever (NSAID) /Nighttime sleep-aid 20 Coated caplets** (**Capsule-shaped tablets) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Caplets. Manufactured by: Avéma Pharma Solutions 10400 NW 29th Terrace, Miami, FL 33172
  • Product Packaging 20ct FC004635 V3

Overview

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

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 childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

Warnings & Precautions
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 nonprescription 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 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 heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin take any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying illness redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Purpose

Purposes Nighttime sleep-aid Pain reliever

Do Not Use

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 heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain

When Using

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying illness 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 (1-800-222-1222) right away.

Storage & Handling

Other information read all warnings and directions before use. Keep carton. store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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