OTC Medication Information: FAMOTIDINE

FAMOTIDINE- famotidine tablet
Wockhardt USA LLC.

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

Label
(click image for full-size original)
FAMOTIDINE
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-972
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color PINK (pink) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code W;972
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-972-01 100 TABLET in 1 BOTTLE None
2 NDC:64679-972-02 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64679-972-02)
3 NDC:64679-972-00 50000 TABLET in 1 DRUM None
4 NDC:64679-972-03 40000 TABLET in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077146 03/07/2005
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 916489953 ANALYSIS (64679-972), LABEL (64679-972), MANUFACTURE (64679-972), PACK (64679-972)

Revised: 11/2019 Wockhardt USA LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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