Famotidine by Little Pharma, Inc. / Annora Pharma Private Limited / Nutra-Med Packaging LLC FAMOTIDINE tablet

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc., Annora Pharma Private Limited, Nutra-Med Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Tips for Managing Heartburn

• Do not lie flat or bend over after eating
• Do not wear tight fitting clothing around th estomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
  

Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages

Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Famotidine USP 10mg

PURPOSE

Acid reducer

INDICATIONS & USAGE

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages

WARNINGS

Alergy Alert

Do not us if allergic to Famotidine or other acid reducers

DO NOT USE

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 DOCTOR

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
• kidney disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

in case of overdose, get medical help or contact a Poison Contol Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and over:
• to relieve symtoms, swallow 1 tablet with a glass of water. Do not chew.
• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 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

STORAGE AND HANDLING

Other Information

• read the directions and warnings before use
• store at 20º to 25ºC (68º to 77ºF)
• protect from moisture

INACTIVE INGREDIENT

carnuba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide

QUESTIONS

Questions or comments?

Call 1-844-243-1241 or email hi@curistrelief.com

PRINCIPAL DISPLAY PANEL

curist

Acid Relief

Famotidine Tablets, 10mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Dut to Acid Indigestion

300 Tablets

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-038
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg  in 10 mg

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-038-23	300 mg in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215766	05/15/2025

Labeler - Little Pharma, Inc. (074328189)

Establishment
Name	Address	ID/FEI	Business Operations
Annora Pharma Private Limited		650980746	manufacture(72559-038)

Establishment
Name	Address	ID/FEI	Business Operations
Nutra-Med Packaging LLC		022004902	pack(72559-038)