Pepcid AC Original Strength

Dosage form: tablet, film coated
Ingredients: Famotidine 10mg
Labeler: McNeil Consumer Pharmaceuticals Co.
NDC Code: 16837-872

Original Strength
Pepcid® AC®

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 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

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

Inactive ingredients

carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

Questions or comments?

1-800-755-4008 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 16837-872-20

ORIGINAL STRENGTH

Pepcid®
AC®

Famotidine Tablets 10 mg
Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

30 Tablets

PEPCID AC   ORIGINAL STRENGTH
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-872
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (Famotidine) Famotidine10 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
HYDROXYPROPYL CELLULOSE (TYPE L) 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
ferric oxide red 
talc 
titanium dioxide 
Product Characteristics
ColorPINK (pale rose) Scoreno score
ShapeSQUARE (rounded edges) Size7mm
FlavorImprint CodePEPCID;AC
Contains    
Packaging
#Item CodePackage Description
1NDC:16837-872-061 BLISTER PACK in 1 CARTON
16 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:16837-872-101 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:16837-872-303 BLISTER PACK in 1 CARTON
310 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:16837-872-314 BLISTER PACK in 1 CARTON
410 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:16837-872-601 BOTTLE, PLASTIC in 1 CARTON
560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
6NDC:16837-872-901 BOTTLE, PLASTIC in 1 CARTON
690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
7NDC:16837-872-203 BLISTER PACK in 1 CARTON
710 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:16837-872-214 BLISTER PACK in 1 CARTON
810 TABLET, FILM COATED in 1 BLISTER PACK
9NDC:16837-872-221 BOTTLE, PLASTIC in 1 CARTON
990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02032510/01/1995
Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)

Revised: 06/2013
 
McNeil Consumer Pharmaceuticals Co.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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