pepcid ac

pepcid ac
SPL v20
SPL
SPL Set ID 54f4086f-e443-4e7e-8c7e-94e152e1c256
Route
oral
Published
Effective Date 2021-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
famotidine (10 mg)
Inactive Ingredients
carnauba wax hydroxypropyl cellulose, unspecified hypromellose, unspecified magnesium stearate microcrystalline cellulose ferric oxide red talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PEPCID;AC Shape: square Color: pink Size: 7 mm Score: 1
Marketing Status
nda completed Since 1995-10-01 Until 2024-08-31

Purpose

Acid reducer

Description

Drug Facts


Medication Information

Active Ingredient

Famotidine 10 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 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

Description

Drug Facts

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

actual size

30 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.

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 10 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 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 (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, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

Principal Display Panel (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

actual size

30 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.

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)