Soothe Chewable Orange

SPL v2

SPL

SPL Set ID 04a78a5c-e3b5-f362-e063-6394a90a0807

Route

ORAL

Published

Effective Date 2023-08-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (34.9 g)

Inactive Ingredients

Sucrose Sorbitol Gelatin .delta.8-tetrahydrocannabinol, (6as-cis)- Potassium Sorbate Turmeric Corn Syrup Water

Identifiers & Packaging

Pill Appearance

Color: orange

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Citric Acid 75mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Citric Acid 75mg

Uses

For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.

Section 51945-4

Warnings

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Directions

Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician

Do not swallow whole

Do Not Use

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Other Information

Store at 68-77 degrees F

Avoid direct sunlight

Inactive Ingredients

Artificial flavors, Gelatin, Delta 8 Tetrahydrocannabinol, Light corn syrup, Potassium Sorbate, Sorbitol, Turmeric powder, Sugar, Water.

If Pregnant Or Breast Feeding

consult a health professional before use

Keep Out of Reach of Children

In case of overdose seek medical help or contact a poison control center right away

Stop Using and Ask A Doctor If

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

Ask A Doctor Before Use If You Are

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

Active Ingredients (in Each Chewable)

Citric Acid 75mg

Structured Label Content

Uses

For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.

Section 51945-4 (51945-4)

Purpose

Antacid

Warnings

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Directions

Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician

Do not swallow whole

Do Not Use (Do not use)

Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

Other Information (Other information)

Store at 68-77 degrees F

Avoid direct sunlight

Inactive Ingredients (Inactive ingredients)

Artificial flavors, Gelatin, Delta 8 Tetrahydrocannabinol, Light corn syrup, Potassium Sorbate, Sorbitol, Turmeric powder, Sugar, Water.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

consult a health professional before use

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose seek medical help or contact a poison control center right away

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

Presently taking a prescription drug, Antacids may interact with certain prescription drugs

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

Citric Acid 75mg

Advanced Ingredient Data

[{"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "34.9", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "2.9", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "6.78", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".DELTA.8-TETRAHYDROCANNABINOL, (6AS-CIS)-", "unii": "ZHX2VN2N5R", "classCode": "IACT", "strengthNumerator": "0.575", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TURMERIC", "unii": "856YO1Z64F", "classCode": "IACT", "strengthNumerator": "0.12", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "33.9", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "27.75", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "1.5", "strengthDenominator": "108.27", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.", "Purpose": "Antacid", "Warnings": "Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician", "Directions": "Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician Do not swallow whole", "Do not use": "Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician", "Other information": "Store at 68-77 degrees F Avoid direct sunlight", "Inactive ingredients": "Artificial flavors, Gelatin, Delta 8 Tetrahydrocannabinol, Light corn syrup, Potassium Sorbate, Sorbitol, Turmeric powder, Sugar, Water.", "If pregnant or breast-feeding": "consult a health professional before use", "Keep out of reach of children": "In case of overdose seek medical help or contact a poison control center right away", "Stop using and ask a doctor if": "Presently taking a prescription drug, Antacids may interact with certain prescription drugs", "Ask a doctor before use if you are": "Presently taking a prescription drug, Antacids may interact with certain prescription drugs", "Active ingredients (in each chewable)": "Citric Acid 75mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:21.159642 · Updated: 2026-03-14T23:07:01.452935