Wal-Zan: Package Insert and Label Information

WAL-ZAN- ranitidine hydrochloride tablet
Walgreen Company

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 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.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

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 right away (1-800-222-1222).

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 PRINTED FOIL UNDER CAP IS OPEN OR TORN.
store at 20° — 25° C (68° — 77° F)
avoid excessive heat or humidity
this product is sodium and sugar free

INACTIVE INGREDIENTS

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

QUESTIONS?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED*

NDC 0363-0362-02

MAXIMUM STRENGTH

Wal-Zan® 150

Ranitidine Tablets, USP 150 mg/Acid Reducer

Prevents & relieves heartburn associated with acid indigestion & sour stomach

200 TABLETS

Compare to Zantac 150® active ingredient‡‡

DISTRIBUTED BY: WALGREEN CO.

5114247/ORG115-F

Walzanlabel200's
(click image for full-size original)
WAL-ZAN
ranitidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0362
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape OVAL (Oval, Shaped) Size 12mm
Flavor Imprint Code 9R
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0362-23 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-0362-23)
2 NDC:0363-0362-50 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-0362-50)
3 NDC:0363-0362-95 1 BOTTLE in 1 CARTON contains a BOTTLE
3 95 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-0362-95)
4 NDC:0363-0362-52 1 BOTTLE in 1 BOTTLE contains a BOTTLE
4 65 TABLET in 1 BOTTLE This package is contained within the BOTTLE (0363-0362-52)
5 NDC:0363-0362-02 1 BOTTLE in 1 CARTON contains a BOTTLE
5 200 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-0362-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200536 06/28/2011
Labeler — Walgreen Company (008965063)
Registrant — Ranbaxy Pharmaceuticals Inc (937890044)
Establishment
Name Address ID/FEI Operations
Shasun Pharmaceuticals Limited 915786829 MANUFACTURE (0363-0362)

Revised: 01/2015 Walgreen Company

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