Alka-seltzer Heartburn Relief Lemon Lime

Alka-seltzer Heartburn Relief Lemon Lime
SPL v9
SPL
SPL Set ID cc21af24-9a5b-6831-e053-2a95a90a0af4
Route
ORAL
Published
Effective Date 2022-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (1650 mg) Anhydrous Citric Acid (1000 mg)
Inactive Ingredients
Aspartame Magnesium Stearate Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER;AF Shape: round Color: white Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-16

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses for the relief of

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Dosage and Administration

Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours
adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours
children under 12 years consult a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have a sodium-restricted diet

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol

Section 51945-4

​ALKA-SELTZER

Fast 4-in-1

Relief of:

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

HEARTBURN RELIEF

LEMON LIME

36 EFFERVESCENT TABLETS

(18 - 2 count pouches)

Section 53413-1

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

Section 53414-9

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

Section 55105-1

Antacid

Antacid

Section 55106-9

Anhydrous citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1650 mg

Section 60561-8

Other information

each tablet contains: sodium 489 mg

phenylketonurics: contains phenylalanine 4.5 mg per tablet

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Lemon Lime in water contains the antacid sodium citrate as the principal active ingredient


Structured Label Content

Indications and Usage (34067-9)

Uses for the relief of

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
Dosage and Administration (34068-7)

Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours
adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours
children under 12 years consult a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have a sodium-restricted diet

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6 (51727-6)

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol

Section 51945-4 (51945-4)

​ALKA-SELTZER

Fast 4-in-1

Relief of:

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

HEARTBURN RELIEF

LEMON LIME

36 EFFERVESCENT TABLETS

(18 - 2 count pouches)

Section 53413-1 (53413-1)

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Antacid

Antacid

Section 55106-9 (55106-9)

Anhydrous citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1650 mg

Section 60561-8 (60561-8)

Other information

each tablet contains: sodium 489 mg

phenylketonurics: contains phenylalanine 4.5 mg per tablet

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Lemon Lime in water contains the antacid sodium citrate as the principal active ingredient


Advanced Ingredient Data


Raw Label Data

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