Healthy Accents Anti Diarrheal

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics

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
• only use attached measuring cup to dose product

adults and children 12 years and over	30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours
children 9-11 years (60-95 lbs)	15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours
children 6-8 years (48-59 lbs)	15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each 30 mL (6 tsp) contains: sodium 15 mg
• store between 20-25°C (68-77°F)
• see side panel for lot number and expiration date

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

1-866-322-2439

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Imodium® A-D active ingredient

loperamide hydrochloride oral suspension

anti-diarrheal

controls the symptoms of diarrhea

mint flavor

NO GLUTEN

8 FL OZ (240mL)

1mg loperamide hydrochloride per 7.5mL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

• Healthy Accents Anti Diarrheal
• loperamide HCl
• LOPERAMIDE HYDROCHLORIDE
• LOPERAMIDE
• ANHYDROUS CITRIC ACID
• CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• GLYCERIN
• CELLULOSE, MICROCRYSTALLINE
• PROPYLENE GLYCOL
• WATER
• SODIUM BENZOATE
• SUCRALOSE
• TITANIUM DIOXIDE
• XANTHAN GUM

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.