FAMOTIDINE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Available from:
Wockhardt USA LLC.
INN (International Name):
FAMOTIDINE
Composition:
FAMOTIDINE 10 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - relieves heartburn associated with acid indigestion and sour stomach - prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Authorization status:
Abbreviated New Drug Application
Authorization number:
64679-972-00, 64679-972-01, 64679-972-02, 64679-972-03

FAMOTIDINE- famotidine tablet

Wockhardt USA LLC.

----------

Famotidine Tablets USP, 10 mg

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 10 mg

OTC - PURPOSE SECTION

Acid reducer

USES

relieves heartburn associated with acid indigestion and sour stomach

prevents heartburn associated with acid indigestion and sour stomach brought on by eating or

drinking certain food and beverages

WARNINGS

Allergy alert: Do not use if you are allergic to famotidine 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

ASK A DOCTOR BEFORE USE IF YOU HAVE

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

frequent chest pain

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this product for more than 14 days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

adults and children 12 years and over:

to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.

to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or

drinking beverages that cause heartburn

do not use more than 2 tablets in 24 hours

children under 12 years: ask a doctor

OTHER INFORMATION

read the directions and warnings before use

store at 25°-30°C (77°-86°F)

protect from moisture

keep the carton and package insert. They contain important information.

INACTIVE INGREDIENT

hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline

cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide.

QUESTIONS OR COMMENTS

Call 1-800-346-6854

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.100510

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 10 mg (OTC)

10 mg – Acid reducer

64679-972-03

FAMOTIDINE

famotidine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 46 79 -9 72

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FAMO TIDINE (UNII: 5QZO15J2Z8 ) (FAMOTIDINE - UNII:5QZO15J2Z8 )

FAMOTIDINE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

HYDRO XYPRO PYL CELLULO SE, LO W SUBSTITUTED (UNII: 216 5RE0 K14)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

PINK (pink)

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

W;9 72

Contains

Wockhardt USA LLC.

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 46 79 -9 72-0 1 10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 7/20 0 5

2

NDC:6 46 79 -9 72-0 2 10 in 1 CARTON

0 3/0 7/20 0 5

2

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:6 46 79 -9 72-

50 0 0 0 in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 7/20 0 5

4

NDC:6 46 79 -9 72-0 3 40 0 0 0 in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 7/20 0 5

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77146

0 3/0 7/20 0 5

Labeler -

Wockhardt USA LLC. (170508365)

Registrant -

Wockhardt Limited (650069115)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wo c kha rdt

Limite d

9 16 48 9 9 53

ANALYSIS(6 46 79 -9 72) , LABEL(6 46 79 -9 72) , MANUFACTURE(6 46 79 -9 72) , PACK(6 46 79 -

9 72)

Revised: 11/2019

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