HEARTBURN RELIEF ORIGINAL STRENGTH- famotidine tablet 
Proficient Rx LP

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Major Pharmaceuticals Heartburn Relief Drug Facts

Active ingredient (in each tablet)

Famotidine 10 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 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

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.

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
keep the carton. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture and light

Inactive ingredients

carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Original Strength

Heartburn Relief

Famotidine Tablets, 10 mg Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn due to Acid Indigestion

COMPARE TO the active ingredient of ORIGINAL STRENGTH PEPCID® AC

ACTUAL SIZE

30 Tablets

TABLETS

63187-999-30
HEARTBURN RELIEF  ORIGINAL STRENGTH
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-999(NDC:0904-5529)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63187-999-1010 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
2NDC:63187-999-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
3NDC:63187-999-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
4NDC:63187-999-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07540009/09/2009
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-999) , RELABEL(63187-999)

Revised: 10/2019
Document Id: 6df77a1c-accd-4559-9a9a-00a030f6ba64
Set id: 5567aaaf-b4f2-4604-b841-c9447e77256c
Version: 3
Effective Time: 20191001
 
Proficient Rx LP