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NDC 69517-0111-50 Fast Pain Relief 200 mg/1 Details

Fast Pain Relief 200 mg/1

Fast Pain Relief is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by HealthLife of USA LLC. The primary component is IBUPROFEN.

MedlinePlus Drug Summary

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 69517-0111-50
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	69517-0111
Product ID	69517-111_8e733e89-3460-49b9-a157-4f2f91bb14cc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fast Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ibuprofen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	IBUPROFEN
Labeler Name	HealthLife of USA LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA079174
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69517-0111-50 (69517011150)

Pricing Information	N/A
NDC Package Code	69517-111-50
Billing NDC	69517011150
Package	50 POUCH in 1 CARTON (69517-111-50) / 2 TABLET, COATED in 1 POUCH
Marketing Start Date	2016-04-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65 Details

Active ingredient(in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
temporarily reduces fever

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

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

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, or asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

under a doctor’s care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

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

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
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
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 right away.

Directions:

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 tablet, 2 tablets may be used
do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

each tablet contains: sodium 0.030 mg
store at 20° to-25°C (68° to-77°F)
avoid excessive heat above 40°C (104°F)
read all product information before using
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, corn starch. hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or Comments

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN Advil®†

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)

†This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®

INGREDIENTS AND APPEARANCE

FAST PAIN RELIEF

ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69517-111
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69517-111-25	25 in 1 CARTON	04/06/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:69517-111-50	50 in 1 CARTON	04/06/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC:69517-111-02	2 in 1 POUCH	04/06/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC:69517-111-10	1000 in 1 BOTTLE	04/06/2016
4	NDC:69517-111-05	500 in 1 BOTTLE
4	NDC:69517-111-30	30 in 1 BOTTLE
4		1 in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079174	01/01/2011

Labeler - HealthLife of USA LLC (079656178)

Name	Address	ID/FEI	Business Operations
Establishment
Granules India Limited		918609236	manufacture(69517-111)

Revised: 6/2017

Document Id: 8e733e89-3460-49b9-a157-4f2f91bb14cc

Set id: a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65

Version: 4

Effective Time: 20170605