AMAZON BASIC CARE IBUPROFEN PM IBUPROFEN AND DIPHENHYDRAMINE CITRATE AMAZON.COM SERVICES LLC FDA Approved Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
FunFoxMeds bottle
Route
ORAL
Applications
ANDA216204
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each caplet) Diphenhydramine citrate USP 38 mg Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide corn starch croscarmellose sodium FD&C blue # 2 glyceryl dibehenate hypromellose lactose monohydrate microcrystalline cellulose palmitic acid polydextrose polyethylene glycol pregelatinized starch (maize) sodium lauryl sulfate sodium starch glycolate stearic acid and titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N. SEATTLE WA 98109 Made in India
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: capsule Color: blue Imprint: DI;200

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
4OD433S209 WK2XYI10QM
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets actual size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Label
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label amazon basic+care For Aches & Pains NDC 72288-061-77 Ibuprofen PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid 120 COATED CAPLETS** **Capsule-Shaped Tablets actual size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (120 Coated Caplets) Bottle Carton Label

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 children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours Other information read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

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 for longer than directed.
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 medical 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.


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