First Aid Direct Anti-Diarrheal — v5

First Aid Direct Anti-Diarrheal

7 Views

Version

v5

Effective date

September 29, 2025

Original packager

Yes

Sections captured

18

Identifiers

Document ID
0a04be19-a326-4471-b3bb-40ba993caf50
Set ID
942b5af1-835e-41dd-bf65-e5b68352aa46
Application numbers
ANDA076497
Product NDCs
42961-103
Package NDCs
42961-103-02
Original packager NDCs

Names & Manufacturers

Brand names
First Aid Direct Anti-Diarrheal
Generic names
FIRST AID DIRECT ANTI-DIARRHEAL
Manufacturer names
Cintas Corp
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
LOPERAMIDE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
77TI35393C
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient (in each caplet) Loperamide HCl 2mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have fever mucus in the stool a history of liver disease
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking antibiotics
Do Not Use (1)

Sequence 1

Do not use if you have bloody or black stool
Dosage And Administration (1)

Sequence 1

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. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs)do not use
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel
Indications And Usage (1)

Sequence 1

Use controls symptoms of diarrhea, including Travelers' Diarrhea
Keep Out Of Reach Of Children (1)

Sequence 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).
Other Safety Information (1)

Sequence 1

Other information store at 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) do not use blister unit is broken or torn
Package Label Principal Display Panel (1)

Sequence 1

Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea *Compare to active ingredient of Imodium A-D® DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN Actual size 12 CAPLETS** Anti-Diarrheal **Capsule-Shaped Tablet Box
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Anti-diarrheal
Questions (1)

Sequence 1

Questions? 1-800-327-2704
Spl Product Data Elements (1)

Sequence 1

First Aid Direct Anti-Diarrheal First Aid Direct Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE LOPERAMIDE STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE
Stop Use (1)

Sequence 1

Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging These may be signs of a serious condition.
Warnings (1)

Sequence 1

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 Ask a doctor or pharmacist before use if you are taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if 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, ask a health professional before use. 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).
When Using (1)

Sequence 1

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

OpenFDA raw payload

{'application_number': ['ANDA076497'],
 'brand_name': ['First Aid Direct Anti-Diarrheal'],
 'generic_name': ['FIRST AID DIRECT ANTI-DIARRHEAL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corp'],
 'package_ndc': ['42961-103-02'],
 'product_ndc': ['42961-103'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['0a04be19-a326-4471-b3bb-40ba993caf50'],
 'spl_set_id': ['942b5af1-835e-41dd-bf65-e5b68352aa46'],
 'substance_name': ['LOPERAMIDE HYDROCHLORIDE'],
 'unii': ['77TI35393C']}