maximum strength

maximum strength
SPL v2
SPL
SPL Set ID 0f343092-4fc7-1fff-e063-6294a90aba6e
Route
oral
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
famotidine (20 mg)
Inactive Ingredients
titanium dioxide polyethylene glycol, unspecified talc hypromellose 2910 (6 mpa.s) magnesium stearate carnauba wax sucralose fd&c blue no. 1 aluminum lake microcrystalline cellulose polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: PAC;20 Shape: freeform Color: blue Size: 9 mm Score: 1
Marketing Status
nda active Since 2024-03-11

Purpose

Acid reducer

Description

Drug Facts


Medication Information

Active Ingredient

Famotidine 20 mg

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
Purpose

Acid reducer

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 10 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, FD&C blue no. 1 aluminum lake, flavors, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sucralose, talc, titanium dioxide

Description

Drug Facts

Principal Display Panel

NDC 16837-889-40

MAXIMUM STRENGTH

Pepcid ®

AC

Famotidine Tablets 20 mg



Acid Reducer

ICY COOL MINT



Flavored Coating

Just One Tablet!



Prevents & Relieves Heartburn



Due to Acid Indigestion

actual size

40 Tablets

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5

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

Section 53414-9

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

Section 54433-8

Do not use if foil inner seal imprinted with SEALED FOR YOUR SAFETY is broken or missing

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
Allergy Alert

Do not use if you are allergic to famotidine or other acid reducers

Questions Or Comments?

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

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
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

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Famotidine 20 mg

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
Purpose

Acid reducer

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 10 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 (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 (Inactive ingredients)

carnauba wax, FD&C blue no. 1 aluminum lake, flavors, hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sucralose, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 16837-889-40

MAXIMUM STRENGTH

Pepcid ®

AC

Famotidine Tablets 20 mg



Acid Reducer

ICY COOL MINT



Flavored Coating

Just One Tablet!



Prevents & Relieves Heartburn



Due to Acid Indigestion

actual size

40 Tablets

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Section 54433-8 (54433-8)

Do not use if foil inner seal imprinted with SEALED FOR YOUR SAFETY is broken or missing

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
Allergy Alert (Allergy alert)

Do not use if you are allergic to famotidine or other acid reducers

Questions Or Comments? (Questions or comments?)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)