CareOne Diarrhea Control

Manufacturer
American Sales Company
Effective date
2025-07-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:09

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 mg

Purpose

Anti-diarrheal

Uses

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

• fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Directions And Dosage

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

Other Label Information

Other information

• each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

CAREone ® Compare to the active ingredient in Imodium® A-D Anti-Diarrheal Oral Solution For Ages 6 Years And Up DIARRHEA CONTROL Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL/Anti Diarrheal Controls the symptoms of diarrhea Mint Flavor Anti-Diarrheal Oral Solution See New Warnings and Directions 4 FL OZ (120mL)

Label Images

careone-diarrhea-control-mint-container-image
careone-diarrhea-control-mint-container-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• symptoms get worse • diarrhea lasts for more than 2 days • you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREone ® Compare to the active ingredient in Imodium® A-D Anti-Diarrheal Oral Solution For Ages 6 Years And Up DIARRHEA CONTROL Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL/Anti Diarrheal Controls the symptoms of diarrhea Mint Flavor Anti-Diarrheal Oral Solution See New Warnings and Directions 4 FL OZ (120mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc073b5ad8-c4b0-4a3b-bf58-c4b6ab14af0a.xml2025-07-23
otccareone-diarrhea-control-mint-container-image.jpg2025-07-23
otc758-of-diarrhea-control.jpg2020-04-07
otcab98e470-5785-4aaf-8aef-91d8d18ccccc.xml2020-04-07
otc758-of-diarrhea-control-1.jpg2018-07-11
otc758-of-diarrhea-control-2.jpg2018-07-11
otce776679a-5990-44d7-a085-65736d1bbfdb.xml2018-07-11