Pepcid ®

Pepcid ®
SPL v7
SPL
SPL Set ID d08984b8-ce03-9e95-e053-2995a90ae6f0
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroxide Ion (165 mg) Famotidine (10 mg) Carbonate Ion (800 mg)
Inactive Ingredients
Acacia Hydroxypropyl Cellulose (70000 Wamw) Starch, Corn Crospovidone (120 .mu.m) Dextrose, Unspecified Form Fd&c Red No. 40 Cellulose Acetate Fd&c Blue No. 1 Aluminum Oxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Maltodextrin D&c Red No. 7 Mineral Oil Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: round Color: purple Size: 18 mm Score: 1
Marketing Status
NDA Active Since 2022-04-19 Until 2024-04-16
Description

Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Purpose

Acid reducer Antacid Antacid

Medication Information

Purpose

Acid reducer Antacid Antacid

Description

Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Use
  • relieves heartburn associated with acid indigestion and sour stomach
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. Antacids and acid reducers may interact with certain prescription drugs.

Section 53414-9

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

Purposes

Acid reducer

Antacid

Antacid

Pepcid ®

DUAL ACTION

Pepcid®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

5

Chewable

Tablets [Lil' Drug Store logo]

Directions
  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing.
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor
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

Other Information
  • each tablet contains: calcium 320 mg, magnesium 70 mg
  • 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
  • do not use if pouch is torn or damaged
Inactive Ingredients

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose

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
Pepcid Complete Berry, Lil' Drug Store ®

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

Tablets [Lil' Drug Store logo]

Active Ingredients (in Each Chewable Tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Structured Label Content

Use
  • relieves heartburn associated with acid indigestion and sour stomach
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. Antacids and acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

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

Purposes

Acid reducer

Antacid

Antacid

Pepcid ®

DUAL ACTION

Pepcid®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

5

Chewable

Tablets [Lil' Drug Store logo]

Directions
  • adults and children 12 years and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing.
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor
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

Other Information (Other information)
  • each tablet contains: calcium 320 mg, magnesium 70 mg
  • 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
  • do not use if pouch is torn or damaged
Inactive Ingredients (Inactive ingredients)

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose

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
Pepcid Complete Berry, Lil' Drug Store ®

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

Tablets [Lil' Drug Store logo]

Active Ingredients (in Each Chewable Tablet) (Active ingredients (in each chewable tablet))

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:44.572830 · Updated: 2026-03-14T23:02:26.872598