Sound Body 44-620-Delisted

Active ingredient (in each tablet)

Ranitidine 150 mg
(as ranitidine hydrochloride USP, 168 mg)

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers.

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers
if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
had heartburn over 3 months. This may be a sign of a more serious condition.
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
heartburn with lightheadedness, sweating, or dizziness

Stop use and ask a doctor if

your heartburn continues or worsens
you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water
- to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
store at 20º-25ºC (68º-77ºF)
avoid excessive heat or humidity
this product is sodium and sugar free
see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

SOUND
BODY™

COMPARE TO THE ACTIVE INGREDIENT IN ZANTAC 150®*

Actual Size

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

MAXIMUM STRENGTH
Acid Reducer
Ranitidine USP 150 mg
Acid Reducer

24 Tablets

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Zantac 150®.
50844 REV0313A62008

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
V#733000 ITEM#022762008blbx

Product of India

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Sound Body 44-620

MAXIMUM STRENGTH ACID REDUCER
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-620
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	9R
Contains

#	Item Code	Package Description
Packaging
1	NDC:50844-620-08	3 in 1 CARTON
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200536	06/15/2013	07/15/2018

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-620)

Name	Address	ID/FEI	Business Operations
Establishment
Shasun Pharmaceuticals Limited		915786829	API MANUFACTURE(50844-620)

Revised: 7/2015

Document Id: 6957ac25-8efe-477a-8212-fa61d709cc17

Set id: 62909184-19f6-4956-8f3a-52a1aad8ec20

Version: 4

Effective Time: 20150715

L.N.K. International, Inc.